Trial Outcomes & Findings for A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors (NCT NCT02452424)
NCT ID: NCT02452424
Last Updated: 2020-03-05
Results Overview
Treatment-emergent Adverse Events (TEAEs) in participants regardless of causality while taking PLX3397 in combination with pembrolizumab are reported
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
78 participants
Primary outcome timeframe
1 year (Dose Escalation); 2 years (Dose Expansion)
Results posted on
2020-03-05
Participant Flow
Dose Escalation: 33 participants who met the inclusion and none of the exclusion criteria were enrolled and received study drug. Dose Expansion: 45 participants with melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, squamous cell carcinoma of the head and neck (SCCHN), and gastrointestinal stromal tumor (GIST) were enrolled.
Dose Escalation: Up to 42 participants with advanced solid tumors (any type) were to be enrolled sequentially in up to 7 cohorts (3+3 design). Dose Expansion: Up to 483 participants were planned with the sample size for each tumor type based on a truncated sequential probability ratio test (max sample size 28 to 48 participants per tumor type).
Participant milestones
| Measure |
Dose Escalation: 400 mg/Day
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 200 mg in the evening).
|
Dose Escalation: 600 mg/Day
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (Liver Metastases
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (no Liver Metastases)
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (Liver Metastases)
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (no Liver Metastases)
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
|
Dose Expansion: Melanoma
Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: NSCLC
Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: SCCHN
Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: GIST
Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
7
|
9
|
4
|
6
|
13
|
8
|
15
|
3
|
6
|
|
Overall Study
COMPLETED
|
2
|
0
|
0
|
1
|
2
|
5
|
3
|
4
|
9
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
7
|
8
|
2
|
1
|
10
|
4
|
6
|
2
|
2
|
Reasons for withdrawal
| Measure |
Dose Escalation: 400 mg/Day
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 200 mg in the evening).
|
Dose Escalation: 600 mg/Day
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (Liver Metastases
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (no Liver Metastases)
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (Liver Metastases)
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (no Liver Metastases)
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
|
Dose Expansion: Melanoma
Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: NSCLC
Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: SCCHN
Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: GIST
Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
2
|
2
|
2
|
6
|
2
|
0
|
5
|
1
|
3
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
3
|
2
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
0
|
1
|
4
|
3
|
0
|
0
|
1
|
|
Overall Study
Progressive disease (per RECIST)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose Escalation: 400 mg/Day
n=4 Participants
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 400 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 200 mg in the evening)..
|
Dose Escalation: 600 mg/Day
n=3 Participants
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (Liver Metastases
n=7 Participants
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (no Liver Metastases)
n=9 Participants
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (Liver Metastases)
n=4 Participants
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (no Liver Metastases)
n=6 Participants
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with of PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening)..
|
Dose Expansion: Melanoma
n=13 Participants
Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: NSCLC
n=8 Participants
Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: Ovarian Cancer
n=15 Participants
Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: SCCHN
n=3 Participants
Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: GIST
n=6 Participants
Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
2 Participants
|
4 Participants
n=19 Participants
|
50 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
1 Participants
|
2 Participants
n=19 Participants
|
28 Participants
n=4 Participants
|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
54.7 years
STANDARD_DEVIATION 10.2 • n=107 Participants
|
51.1 years
STANDARD_DEVIATION 17.0 • n=206 Participants
|
55.9 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
72.0 years
STANDARD_DEVIATION 5.3 • n=31 Participants
|
61.7 years
STANDARD_DEVIATION 8.7 • n=30 Participants
|
61.8 years
STANDARD_DEVIATION 8.3 • n=3 Participants
|
57.0 years
STANDARD_DEVIATION 11.3 • n=6 Participants
|
60.4 years
STANDARD_DEVIATION 12.5 • n=114 Participants
|
52.7 years
STANDARD_DEVIATION 16.3
|
59.7 years
STANDARD_DEVIATION 8.8 • n=19 Participants
|
59.3 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
15 Participants
n=114 Participants
|
0 Participants
|
2 Participants
n=19 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
3 Participants
|
4 Participants
n=19 Participants
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
14 Participants
n=114 Participants
|
3 Participants
|
5 Participants
n=19 Participants
|
68 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
9 participants
n=7 Participants
|
4 participants
n=31 Participants
|
6 participants
n=30 Participants
|
13 participants
n=3 Participants
|
8 participants
n=6 Participants
|
15 participants
n=114 Participants
|
3 participants
|
6 participants
n=19 Participants
|
78 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 year (Dose Escalation); 2 years (Dose Expansion)Population: Safety events were assessed in the Safety Population.
Treatment-emergent Adverse Events (TEAEs) in participants regardless of causality while taking PLX3397 in combination with pembrolizumab are reported
Outcome measures
| Measure |
Dose Escalation: 400 mg/Day
n=4 Participants
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 200 mg in the evening).
|
Dose Escalation: 600 mg/Day
n=3 Participants
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (Liver Metastases
n=7 Participants
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (no Liver Metastases)
n=9 Participants
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (Liver Metastases)
n=4 Participants
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (no Liver Metastases)
n=6 Participants
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
|
Dose Expansion: Melanoma
n=13 Participants
Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: NSCLC
n=8 Participants
Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: Ovarian Cancer
n=15 Participants
Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: SCCHN
n=3 Participants
Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: GIST
n=6 Participants
Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment-emergent Adverse Events (TEAEs) in Participants Regardless of Causality While Taking PLX3397 in Combination With Pembrolizumab
|
4 Participants
|
3 Participants
|
7 Participants
|
9 Participants
|
4 Participants
|
6 Participants
|
12 Participants
|
8 Participants
|
15 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 year (Dose Escalation); 2 years (Dose Expansion)Population: Overall best response was assessed in the Efficacy Analysis Set.
Objective response rate was defined as the proportion of subjects who achieved a best disease response of either Complete or Partial (CR or PR) based on the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed generally by MRI, CT, or PET-CT and are summarized as: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Participants who discontinued study therapy due to clinical progression, radiographic progression, or death without the required tumor assessments were considered to be non-responders in the Objective Response Rate (ORR) calculation. The efficacy analysis included all subjects with baseline tumor measurements who received at least 1 dose of study drug.
Outcome measures
| Measure |
Dose Escalation: 400 mg/Day
n=4 Participants
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 200 mg in the evening).
|
Dose Escalation: 600 mg/Day
n=3 Participants
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (Liver Metastases
n=7 Participants
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (no Liver Metastases)
n=9 Participants
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (Liver Metastases)
n=4 Participants
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (no Liver Metastases)
n=6 Participants
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
|
Dose Expansion: Melanoma
n=13 Participants
Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: NSCLC
n=8 Participants
Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: Ovarian Cancer
n=15 Participants
Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: SCCHN
n=3 Participants
Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: GIST
n=6 Participants
Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of the Percentage of Participants With Objective Response Rate Assessed by RECIST v1.1 During Pembrolizumab and PLX3397
Stable disease
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Summary of the Percentage of Participants With Objective Response Rate Assessed by RECIST v1.1 During Pembrolizumab and PLX3397
Complete response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of the Percentage of Participants With Objective Response Rate Assessed by RECIST v1.1 During Pembrolizumab and PLX3397
Partial response
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Summary of the Percentage of Participants With Objective Response Rate Assessed by RECIST v1.1 During Pembrolizumab and PLX3397
Progressive disease
|
2 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
9 Participants
|
2 Participants
|
3 Participants
|
|
Summary of the Percentage of Participants With Objective Response Rate Assessed by RECIST v1.1 During Pembrolizumab and PLX3397
Not evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of the Percentage of Participants With Objective Response Rate Assessed by RECIST v1.1 During Pembrolizumab and PLX3397
Not assessed for response
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Dose Escalation: 400 mg/Day
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Dose Escalation: 600 mg/Day
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Escalation: 600 mg/Day (Liver Metastases
Serious events: 3 serious events
Other events: 7 other events
Deaths: 2 deaths
Dose Escalation: 600 mg/Day (no Liver Metastases)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 6 deaths
Dose Escalation: 800 mg/Day (Liver Metastases)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Dose Escalation: 800 mg/Day (no Liver Metastases)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Expansion: Melanoma
Serious events: 3 serious events
Other events: 12 other events
Deaths: 5 deaths
Dose Expansion: NSCLC
Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths
Dose Expansion: Ovarian Cancer
Serious events: 5 serious events
Other events: 15 other events
Deaths: 3 deaths
Dose Expansion: SCCHN
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Expansion: GIST
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Escalation: 400 mg/Day
n=4 participants at risk
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 200 mg in the evening).
|
Dose Escalation: 600 mg/Day
n=3 participants at risk
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (Liver Metastases
n=7 participants at risk
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (no Liver Metastases)
n=9 participants at risk
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (Liver Metastases)
n=4 participants at risk
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (no Liver Metastases)
n=6 participants at risk
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
|
Dose Expansion: Melanoma
n=13 participants at risk
Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: NSCLC
n=8 participants at risk
Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: Ovarian Cancer
n=15 participants at risk
Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: SCCHN
n=3 participants at risk
Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: GIST
n=6 participants at risk
Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Obstruction gastric
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Parotitis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Hydrocephalus
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
Other adverse events
| Measure |
Dose Escalation: 400 mg/Day
n=4 participants at risk
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 200 mg in the evening).
|
Dose Escalation: 600 mg/Day
n=3 participants at risk
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (Liver Metastases
n=7 participants at risk
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 600 mg/Day (no Liver Metastases)
n=9 participants at risk
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (Liver Metastases)
n=4 participants at risk
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
|
Dose Escalation: 800 mg/Day (no Liver Metastases)
n=6 participants at risk
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
|
Dose Expansion: Melanoma
n=13 participants at risk
Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: NSCLC
n=8 participants at risk
Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: Ovarian Cancer
n=15 participants at risk
Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: SCCHN
n=3 participants at risk
Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
Dose Expansion: GIST
n=6 participants at risk
Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Dysgeusia (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
23.1%
3/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Encephalopathy (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Endocrine disorders
Adrenal insufficiency (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Endocrine disorders
Hyperthyroidism (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Oral herpes (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Dizziness (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
3/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
38.5%
5/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Dysarthria (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Ear and labyrinth disorders
Ear discomfort (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Anemia (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
22.2%
2/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
38.5%
5/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
40.0%
6/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Leukopenia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Lymphadenopathy (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Lymphopenia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Neutropenia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Pancytopenia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Splenic infarction (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
22.2%
2/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Atrial fibrillation (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Sinus bradycardia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Conjunctival haemorrhage (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Eye oedema
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Eye swelling
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Uveitis (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Vision blurred (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal discomfort (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
22.2%
2/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
5/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain lower (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
22.2%
2/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Breath odor
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Constipation (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
22.2%
2/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
3/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Diarrhoea (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
44.4%
4/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
38.5%
5/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
5/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Dry mouth (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Dysphagia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
3/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Glossodynia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Nausea (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
42.9%
3/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
3/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
75.0%
3/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
30.8%
4/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
4/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
5/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
100.0%
3/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Obstruction gastric (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Paraesthesia oral (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Rectal haemorrhage (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Retching (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Stomatitis (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Vomiting (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
22.2%
2/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
23.1%
3/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
62.5%
5/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
3/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Axillary pain
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Chest pain (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Chills (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
23.1%
3/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Decreased activity
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Device occlusion (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Discomfort
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Early satiety
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Face oedema
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Facial pain (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Fatigue (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
55.6%
5/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
46.2%
6/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
37.5%
3/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
60.0%
9/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
100.0%
3/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
3/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Generalized oedema (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Influenza-like illness (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Localised oedema
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Malaise (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Oedema peripheral (All grades)
|
50.0%
2/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Pain (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
37.5%
3/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Peripheral swelling (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Pyrexia (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
57.1%
4/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
22.2%
2/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
3/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
53.3%
8/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Bile duct obstruction (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Drug-induced liver injury (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Hepatic pain (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Hyperbilirubinemia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Bacteremia (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Bacterial infection (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Fungal infection (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Fungal skin infection (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Furuncle (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Mastitis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Oral candidiasis (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Parotitis (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Pneumonia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Rectal abscess (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Root canal infection (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Urinary tract infection (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Urinary tract infection bacterial (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Urosepsis (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Arthropod bite (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Contusion (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Fall (All grades)
|
50.0%
2/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Infusion-related reaction (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Laceration (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Procedure pain
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Alanine aminotransferase increased (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
3/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
38.5%
5/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
37.5%
3/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
60.0%
9/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
4/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Aspartate aminotransferase increased (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
44.4%
4/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
3/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
46.2%
6/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
37.5%
3/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
53.3%
8/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
4/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood alkaline phosphatase increased (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
3/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
30.8%
4/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood bilirubin increased (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood creatinine increased (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood creatinine phosphokinase increased
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood glucose increased
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood potassium increased (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood thyroid stimulating hormone increased (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Breath sounds abnormal (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Gamma-glutamyltransferase increased (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
30.8%
4/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
3/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Haemoglobin decreased (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Heart rate irregular
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Liver function test abnormal (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Mean cell haemoglobin decreased
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Mean cell volume decreased
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Neutrophil count decreased (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Nutritional condition abnormal
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Palpatory finding abnormal
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Platelet count decreased (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Prothrombin time prolonged (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Thyroxine free decreased (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Transaminase increased (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
3/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Troponin increased (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Weight decreased (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
White blood cell count decreased (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
22.2%
2/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
23.1%
3/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Decreased appetite (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
42.9%
3/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
3/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
30.8%
4/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
37.5%
3/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
40.0%
6/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Dehydration (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
23.1%
3/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
3/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
3/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypomagnaesemia (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
3/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypophosphataemia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
22.2%
2/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain (All grades)
|
50.0%
2/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
26.7%
4/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Flank pain (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Groin pain (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle oedema
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscular Stiffness (All Grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
30.8%
4/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Neck pain (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
22.2%
2/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Cerebral infarction (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Cognitive disorder (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Haemorrhage intracranial (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Headache (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
22.2%
2/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
23.1%
3/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Hydrocephalus (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Hypoaesthesia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Migraine with aura (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Paraesthesia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Presyncope (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Syncope (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Anxiety (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Confusional state (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Hallucination (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Insomnia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Mental status changes (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Haematuria (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Proteinuria (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Reproductive system and breast disorders
Penile discharge (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Reproductive system and breast disorders
Perineal pain (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar lung disease
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
3/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
3/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
30.8%
4/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
62.5%
5/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
5/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
44.4%
4/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
4/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discharge discolouration
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema (All grade)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
26.7%
4/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Cold sweat (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Erythema (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
37.5%
3/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Night sweats (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
42.9%
3/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
23.1%
3/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
62.5%
5/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
37.5%
3/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash generalized (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
13.3%
2/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
22.2%
2/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
30.8%
4/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
2/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
53.3%
8/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
3/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Skin lesion (All grades)
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
11.1%
1/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
23.1%
3/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
1/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Hyperaemia
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.7%
1/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Hypertension (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
3/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Hypotension (All grades)
|
25.0%
1/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/9 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
15.4%
2/13 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/8 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
6.7%
1/15 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place