Trial Outcomes & Findings for Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma (NCT NCT02180711)
NCT ID: NCT02180711
Last Updated: 2025-10-15
Results Overview
Treatment-emergent adverse events were used to characterize the safety profile of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory follicular lymphoma (R/R FL).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
113 participants
Primary outcome timeframe
From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study).
Results posted on
2025-10-15
Participant Flow
Participant milestones
| Measure |
P1: RR Acalabrutinib 100 mg BID
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID))
|
P1: RR Acalabrutinib 100 mg BID + Rituximab
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P1: RR Acalabrutinib 200 mg QD
(Relapsed/Refractory Cohort: Acalabrutinib 200 mg once a day (QD))
|
P1: TN Acalabrutinib 100 mg BID + Rituximab
(Treatment Naive Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P2: Acalabrutinib
(Acalabrutinib 100 mg Twice a Day (BID))
|
P2: Acalabrutinib + Rituximab
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2 + Lenalidomide 15 mg Daily (QD))
|
P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2 + Lenalidomide 20 mg Daily (QD))
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
2
|
13
|
43
|
1
|
8
|
21
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
2
|
13
|
43
|
1
|
8
|
21
|
Reasons for withdrawal
| Measure |
P1: RR Acalabrutinib 100 mg BID
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID))
|
P1: RR Acalabrutinib 100 mg BID + Rituximab
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P1: RR Acalabrutinib 200 mg QD
(Relapsed/Refractory Cohort: Acalabrutinib 200 mg once a day (QD))
|
P1: TN Acalabrutinib 100 mg BID + Rituximab
(Treatment Naive Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P2: Acalabrutinib
(Acalabrutinib 100 mg Twice a Day (BID))
|
P2: Acalabrutinib + Rituximab
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2 + Lenalidomide 15 mg Daily (QD))
|
P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2 + Lenalidomide 20 mg Daily (QD))
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
7
|
0
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
4
|
3
|
0
|
3
|
2
|
|
Overall Study
- Disease Progression
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
- Subject Started Alternative Cancer Therapy
|
7
|
6
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
- Study Terminated by Sponsor
|
2
|
3
|
0
|
5
|
32
|
0
|
4
|
13
|
|
Overall Study
- Enrolled into Follow-up Study
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
- Other
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
P1: RR Acalabrutinib 100 mg BID
n=12 Participants
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID))
|
P1: RR Acalabrutinib 100 mg BID + Rituximab
n=13 Participants
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P1: RR Acalabrutinib 200 mg QD
n=2 Participants
(Relapsed/Refractory Cohort: Acalabrutinib 200 mg once a day (QD))
|
P1: TN Acalabrutinib 100 mg BID + Rituximab
n=13 Participants
(Treatment Naive Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P2: Acalabrutinib
n=43 Participants
(Acalabrutinib 100 mg Twice a Day (BID))
|
P2: Acalabrutinib + Rituximab
n=1 Participants
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg
n=8 Participants
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2 + Lenalidomide 15 mg Daily (QD))
|
P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg
n=21 Participants
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2 + Lenalidomide 20 mg Daily (QD))
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.3 Years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
66.7 Years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
59.0 Years
STANDARD_DEVIATION 21.2 • n=5 Participants
|
59.6 Years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
66.0 Years
STANDARD_DEVIATION 10.0 • n=21 Participants
|
43.0 Years
STANDARD_DEVIATION NA • n=10 Participants
|
62.5 Years
STANDARD_DEVIATION 9.7 • n=115 Participants
|
63.0 Years
STANDARD_DEVIATION 9.7 • n=6 Participants
|
64.0 Years
STANDARD_DEVIATION 11.2 • n=6 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
48 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
15 Participants
n=6 Participants
|
65 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
17 Participants
n=6 Participants
|
101 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
17 Participants
n=6 Participants
|
101 Participants
n=6 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
16 Participants
n=6 Participants
|
101 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study).Treatment-emergent adverse events were used to characterize the safety profile of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory follicular lymphoma (R/R FL).
Outcome measures
| Measure |
Part 1: Acalabrutinib 100 mg BID
n=12 Participants
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID))
|
Part 1: Acalabrutinib 100 mg BID + Rituximab
n=13 Participants
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
Part 1: Relapsed or Refractory Acalabrutinib 200 mg QD
n=2 Participants
(Relapsed/Refractory Cohort: Acalabrutinib 200 mg once a day (QD))
|
Part 1: Acalabrutinib 100 mg Rituximab
n=13 Participants
(Treatment Naive Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
|---|---|---|---|---|
|
Part 1: Incidence of Treatment-emergent Adverse Events.
|
12 Number of participants
|
13 Number of participants
|
2 Number of participants
|
13 Number of participants
|
PRIMARY outcome
Timeframe: Based on all response assessments since the first dose of study drug until study discontinuation or the initiation of subsequent anticancer therapy, whichever was earlier, up to 65.1 months (the maximum participant's time on this study).The objective response rate (ORR) is used to characterize the activity of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
Outcome measures
| Measure |
Part 1: Acalabrutinib 100 mg BID
n=43 Participants
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID))
|
Part 1: Acalabrutinib 100 mg BID + Rituximab
n=1 Participants
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
Part 1: Relapsed or Refractory Acalabrutinib 200 mg QD
(Relapsed/Refractory Cohort: Acalabrutinib 200 mg once a day (QD))
|
Part 1: Acalabrutinib 100 mg Rituximab
(Treatment Naive Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
|---|---|---|---|---|
|
Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL).
|
60.5 Percentage of participants
Interval 44.4 to 75.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 54.3 months (the maximum participant's time on this study).Treatment-emergent adverse events were used to characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in participants with relapsed/refractory follicular lymphoma (R/R FL).
Outcome measures
| Measure |
Part 1: Acalabrutinib 100 mg BID
n=8 Participants
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID))
|
Part 1: Acalabrutinib 100 mg BID + Rituximab
n=21 Participants
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
Part 1: Relapsed or Refractory Acalabrutinib 200 mg QD
(Relapsed/Refractory Cohort: Acalabrutinib 200 mg once a day (QD))
|
Part 1: Acalabrutinib 100 mg Rituximab
(Treatment Naive Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
|---|---|---|---|---|
|
Part 3: Incidence of Treatment-emergent Adverse Events.
|
8 Number of participants
|
21 Number of participants
|
—
|
—
|
Adverse Events
P1: RR Acalabrutinib 100 mg BID
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
P1: RR Acalabrutinib 100 mg BID + Rituximab
Serious events: 5 serious events
Other events: 13 other events
Deaths: 1 deaths
P1: RR Acalabrutinib 200 mg QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
P1: TN Acalabrutinib 100 mg BID + Rituximab
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
P2: Acalabrutinib
Serious events: 9 serious events
Other events: 41 other events
Deaths: 7 deaths
P2: Acalabrutinib + Rituximab
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg
Serious events: 4 serious events
Other events: 8 other events
Deaths: 1 deaths
P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg
Serious events: 11 serious events
Other events: 21 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
P1: RR Acalabrutinib 100 mg BID
n=12 participants at risk
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID))
|
P1: RR Acalabrutinib 100 mg BID + Rituximab
n=13 participants at risk
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P1: RR Acalabrutinib 200 mg QD
n=2 participants at risk
(Relapsed/Refractory Cohort: Acalabrutinib 200 mg once a day (QD))
|
P1: TN Acalabrutinib 100 mg BID + Rituximab
n=13 participants at risk
(Treatment Naive Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P2: Acalabrutinib
n=43 participants at risk
(Acalabrutinib 100 mg Twice a Day (BID))
|
P2: Acalabrutinib + Rituximab
n=1 participants at risk
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg
n=8 participants at risk
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2 + Lenalidomide 15 mg Daily (QD))
|
P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg
n=21 participants at risk
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2 + Lenalidomide 20 mg Daily (QD))
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.3%
3/21 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Septic shock
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac valve fibroelastoma
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Chest pain
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Gait disturbance
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Covid-19
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
19.0%
4/21 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
Other adverse events
| Measure |
P1: RR Acalabrutinib 100 mg BID
n=12 participants at risk
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID))
|
P1: RR Acalabrutinib 100 mg BID + Rituximab
n=13 participants at risk
(Relapsed/Refractory Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P1: RR Acalabrutinib 200 mg QD
n=2 participants at risk
(Relapsed/Refractory Cohort: Acalabrutinib 200 mg once a day (QD))
|
P1: TN Acalabrutinib 100 mg BID + Rituximab
n=13 participants at risk
(Treatment Naive Cohort: Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P2: Acalabrutinib
n=43 participants at risk
(Acalabrutinib 100 mg Twice a Day (BID))
|
P2: Acalabrutinib + Rituximab
n=1 participants at risk
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2)
|
P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg
n=8 participants at risk
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2 + Lenalidomide 15 mg Daily (QD))
|
P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg
n=21 participants at risk
(Acalabrutinib 100 mg Twice a Day (BID) + Rituximab 375 mg/m2 + Lenalidomide 20 mg Daily (QD))
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Penile infection
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Pharyngitis
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Sinusitis
|
41.7%
5/12 • Number of events 15 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
30.8%
4/13 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.1%
3/13 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Suspected covid-19
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Tooth abscess
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Viral infection
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
4/12 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
30.8%
4/13 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.3%
3/21 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
38.5%
5/13 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
25.0%
2/8 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
2/12 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
30.8%
4/13 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
50.0%
1/2 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
38.5%
5/13 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
11.6%
5/43 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
28.6%
6/21 • Number of events 7 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Eyelid contusion
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.1%
3/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Incision site swelling
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
30.8%
4/13 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
37.5%
3/8 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
38.1%
8/21 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
11.6%
5/43 • Number of events 9 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Cardiac disorders
Pericarditis constrictive
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Blood creatinine increased
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
18.6%
8/43 • Number of events 15 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Cardiac murmur
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
11.6%
5/43 • Number of events 16 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 11 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
33.3%
7/21 • Number of events 11 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Platelet count decreased
|
8.3%
1/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.3%
3/21 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Urine output decreased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Weight decreased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
11.6%
5/43 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
25.0%
2/8 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
Weight increased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.3%
3/21 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
2/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.1%
3/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
19.0%
4/21 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
30.8%
4/13 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
19.0%
4/21 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
1/12 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
2/12 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
38.5%
5/13 • Number of events 7 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.0%
6/43 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
28.6%
6/21 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
3/12 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.1%
3/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.0%
6/43 • Number of events 7 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
37.5%
3/8 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.3%
3/21 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc annular tear
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.0%
6/43 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
1/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
30.8%
4/13 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
16.3%
7/43 • Number of events 11 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
25.0%
2/8 • Number of events 7 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
19.0%
4/21 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.1%
3/13 • Number of events 7 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.0%
6/43 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Congenital, familial and genetic disorders
Pseudoxanthoma elasticum
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Dizziness
|
25.0%
3/12 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
30.8%
4/13 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
25.0%
2/8 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
19.0%
4/21 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Headache
|
58.3%
7/12 • Number of events 14 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
38.5%
5/13 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
46.2%
6/13 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
34.9%
15/43 • Number of events 18 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
37.5%
3/8 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
38.1%
8/21 • Number of events 9 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Memory impairment
|
33.3%
4/12 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
2/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
16.3%
7/43 • Number of events 14 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
25.0%
2/8 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
2/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Paraesthesia
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Psychiatric disorders
Anxiety
|
16.7%
2/12 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.1%
3/13 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Psychiatric disorders
Confusional state
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Ear and labyrinth disorders
Eustachian tube disorder
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.0%
6/43 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Psychiatric disorders
Sleep disorder
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Renal and urinary disorders
Nocturia
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
1/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.7%
5/12 • Number of events 7 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.1%
3/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.3%
10/43 • Number of events 13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
37.5%
3/8 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
33.3%
7/21 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
3/12 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
11.6%
5/43 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
28.6%
6/21 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.3%
3/21 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.1%
3/13 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.3%
3/21 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
2/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
19.0%
4/21 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Ear and labyrinth disorders
Tympanosclerosis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
25.0%
3/12 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
2/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
25.0%
2/8 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Ear and labyrinth disorders
Vertigo positional
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Guttate psoriasis
|
8.3%
1/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.7%
2/12 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
37.5%
3/8 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
28.6%
6/21 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Endocrine disorders
Hyperprolactinaemia
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
2/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
11.6%
5/43 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
25.0%
2/8 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.8%
5/21 • Number of events 11 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
11.6%
5/43 • Number of events 7 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
19.0%
4/21 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Endocrine disorders
Hypogonadism
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Vascular disorders
Haematoma
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Vascular disorders
Hot flush
|
16.7%
2/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Vascular disorders
Hypertension
|
25.0%
3/12 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
11.6%
5/43 • Number of events 12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Vascular disorders
Thrombosis
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Eye disorders
Cataract
|
8.3%
1/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Eye disorders
Conjunctival haemorrhage
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Eye disorders
Dry eye
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Eye disorders
Eyelid bleeding
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Eye disorders
Ocular hyperaemia
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Eye disorders
Scleral hyperaemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
50.0%
1/2 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
25.0%
2/8 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.3%
3/21 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
16.7%
2/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.1%
3/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
19.0%
4/21 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.1%
3/13 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.1%
3/13 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
16.3%
7/43 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.8%
5/21 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Diarrhoea
|
41.7%
5/12 • Number of events 11 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
38.5%
5/13 • Number of events 11 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
53.8%
7/13 • Number of events 19 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
27.9%
12/43 • Number of events 14 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
50.0%
4/8 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
57.1%
12/21 • Number of events 21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.1%
3/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
11.6%
5/43 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
42.9%
9/21 • Number of events 24 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
38.5%
5/13 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
30.8%
4/13 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
34.9%
15/43 • Number of events 18 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
38.1%
8/21 • Number of events 12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 10 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
2/12 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
4/12 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
30.8%
4/13 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.8%
5/21 • Number of events 7 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Asthenia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Chest discomfort
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Chest pain
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Chills
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.7%
2/43 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Fatigue
|
58.3%
7/12 • Number of events 11 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
61.5%
8/13 • Number of events 12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
53.8%
7/13 • Number of events 15 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
34.9%
15/43 • Number of events 25 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
37.5%
3/8 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
33.3%
7/21 • Number of events 13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Feeling abnormal
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Localised oedema
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Malaise
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
14.3%
3/21 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Oedema
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.5%
2/21 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
30.8%
4/13 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
9.3%
4/43 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.8%
5/21 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Peripheral swelling
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.1%
3/13 • Number of events 6 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
100.0%
1/1 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
25.0%
2/8 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
23.8%
5/21 • Number of events 5 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Immune system disorders
Immunisation reaction
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Acarodermatitis
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Bronchitis
|
16.7%
2/12 • Number of events 4 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.0%
3/43 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Covid-19
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
18.6%
8/43 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
28.6%
6/21 • Number of events 8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
15.4%
2/13 • Number of events 3 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Conjunctivitis
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Cystitis
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
7.7%
1/13 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/12 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
12.5%
1/8 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Herpes zoster
|
16.7%
2/12 • Number of events 2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
2.3%
1/43 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
4.8%
1/21 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • Number of events 1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/2 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/13 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/43 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/1 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/8 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
0.00%
0/21 • Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3.
Adverse events are coded per MedDRA version 25.0 for Part 1. Adverse events are coded per MedDRA version 26.1 for Part 2 and Part 3.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60