Trial Outcomes & Findings for A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab (NCT NCT01975831)
NCT ID: NCT01975831
Last Updated: 2022-10-12
Results Overview
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, electrocardiograms, magnetic resonance imaging, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 90 days after the last dose of study treatment. AEs were considered to be treatment emergent (TEAE) if they occurred or worsened in severity after the first dose of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
104 participants
Primary outcome timeframe
Up to 36 months
Results posted on
2022-10-12
Participant Flow
Participant milestones
| Measure |
Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme
Subjects received durvalumab (0.3 mg/kg every 2 weeks \[Q2W\] for 13 cycles) and tremelimumab (3 mg/kg every 4 weeks \[Q4W\] for 6 cycles, then every 12 weeks \[Q12W\]). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as intravenous (IV) infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 1 mg/kg Durva + 3 mg/kg Treme
Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 3 mg/kg Treme
Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 1 mg/kg Treme
Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Ovarian Cancer
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Colorectal Cancer
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Non-triple Negative Breast Cancer
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Renal Cell Carcinoma
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Cervical Cancer
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
11
|
4
|
4
|
19
|
16
|
16
|
16
|
15
|
|
Overall Study
COMPLETED
|
0
|
2
|
0
|
0
|
1
|
2
|
0
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
4
|
4
|
18
|
14
|
16
|
15
|
12
|
Reasons for withdrawal
| Measure |
Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme
Subjects received durvalumab (0.3 mg/kg every 2 weeks \[Q2W\] for 13 cycles) and tremelimumab (3 mg/kg every 4 weeks \[Q4W\] for 6 cycles, then every 12 weeks \[Q12W\]). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as intravenous (IV) infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 1 mg/kg Durva + 3 mg/kg Treme
Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 3 mg/kg Treme
Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 1 mg/kg Treme
Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Ovarian Cancer
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Colorectal Cancer
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Non-triple Negative Breast Cancer
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Renal Cell Carcinoma
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Cervical Cancer
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
2
|
0
|
1
|
1
|
3
|
4
|
1
|
|
Overall Study
Death
|
1
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Progressive Disease
|
1
|
3
|
2
|
4
|
13
|
9
|
10
|
8
|
10
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
0
|
3
|
1
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Initiation of Subsequent Therapy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
|
Overall Study
Entered Hospice
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Unable to Treat Within Protocol Windows
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab
Baseline characteristics by cohort
| Measure |
Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme
n=3 Participants
Subjects received durvalumab (0.3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 1 mg/kg Durva + 3 mg/kg Treme
n=11 Participants
Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 3 mg/kg Treme
n=4 Participants
Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 1 mg/kg Treme
n=4 Participants
Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Ovarian Cancer
n=19 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Colorectal Cancer
n=16 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Non-triple Negative Breast Cancer
n=16 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Renal Cell Carcinoma
n=16 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Cervical Cancer
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS 2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 7.51 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 11.93 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 11.35 • n=4 Participants
|
59.7 years
STANDARD_DEVIATION 10.91 • n=21 Participants
|
49.7 years
STANDARD_DEVIATION 9.79 • n=8 Participants
|
55.4 years
STANDARD_DEVIATION 14.31 • n=8 Participants
|
59.7 years
STANDARD_DEVIATION 9.71 • n=24 Participants
|
53.0 years
STANDARD_DEVIATION 11.46 • n=42 Participants
|
55.5 years
STANDARD_DEVIATION 11.51 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
76 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
93 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
83 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS 0
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS 1
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
50 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: The population comprises all subjects who received any dose of study treatment.
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, electrocardiograms, magnetic resonance imaging, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 90 days after the last dose of study treatment. AEs were considered to be treatment emergent (TEAE) if they occurred or worsened in severity after the first dose of study treatment.
Outcome measures
| Measure |
Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme
n=3 Participants
Subjects received durvalumab (0.3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 1 mg/kg Durva + 3 mg/kg Treme
n=11 Participants
Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 3 mg/kg Treme
n=4 Participants
Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 1 mg/kg Treme
n=4 Participants
Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Ovarian Cancer
n=19 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Colorectal Cancer
n=16 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Non-triple Negative Breast Cancer
n=16 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Renal Cell Carcinoma
n=16 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Cervical Cancer
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Serious TEAE
|
2 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
TEAE leading to treatment discontinuation
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
3 Participants
|
11 Participants
|
4 Participants
|
4 Participants
|
19 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The population comprises all subjects who received at least one dose of the durvalumab/tremelimumab combination and had the baseline and at least one post-baseline assessment of any efficacy endpoint (clinical or radiological) or a report of death.
Immune-related tumor response was evaluated by computed tomography at Baseline and every 4 to 8 or 12 weeks on study. Tumor response was designated according to the immune-related Response Criteria (irRC) (Wolchok et al 2009) into the following categories: immune-related complete response (irCR) requires disappearance of all lesions in two consecutive observations not less than 4 weeks apart; immune-related partial response (irPR) requires ≥ 50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart; immune-related stable disease (irSD) is assigned when neither a 50% decrease from baseline tumor burden nor a 25% increase in tumor burden from nadir can be established; immune-related progressive disease (irPD) requires a ≥ 25% increase from nadir in tumor burden at any single time point in two consecutive observations at least 4 weeks apart.
Outcome measures
| Measure |
Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme
n=3 Participants
Subjects received durvalumab (0.3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 1 mg/kg Durva + 3 mg/kg Treme
n=10 Participants
Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 3 mg/kg Treme
n=3 Participants
Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 1 mg/kg Treme
n=4 Participants
Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Ovarian Cancer
n=18 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Colorectal Cancer
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Non-triple Negative Breast Cancer
n=16 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Renal Cell Carcinoma
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Cervical Cancer
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Best Overall Immune-related Tumor Response
irCR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Best Overall Immune-related Tumor Response
irPR
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Best Overall Immune-related Tumor Response
irSD
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
11 Participants
|
3 Participants
|
|
Number of Subjects With Best Overall Immune-related Tumor Response
irPD
|
1 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
10 Participants
|
12 Participants
|
12 Participants
|
2 Participants
|
7 Participants
|
|
Number of Subjects With Best Overall Immune-related Tumor Response
Not evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The population comprises all subjects who received at least one dose of the durvalumab/tremelimumab combination and had the baseline and at least one post-baseline assessment of any efficacy endpoint (clinical or radiological) or a report of death.
Tumor response was evaluated using computed tomography and categorized according to RECIST (version 1.1) at Baseline and every 4 to 8 or 12 weeks on study. Per RECIST 1.1 (Eisenhauer et al 2009), target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.
Outcome measures
| Measure |
Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme
n=3 Participants
Subjects received durvalumab (0.3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 1 mg/kg Durva + 3 mg/kg Treme
n=10 Participants
Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 3 mg/kg Treme
n=3 Participants
Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 1 mg/kg Treme
n=4 Participants
Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Ovarian Cancer
n=18 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Colorectal Cancer
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Non-triple Negative Breast Cancer
n=16 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Renal Cell Carcinoma
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Cervical Cancer
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PR
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
SD
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PD
|
1 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
11 Participants
|
12 Participants
|
11 Participants
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: The population comprises all subjects who received at least one dose of the durvalumab/tremelimumab combination and had the baseline and at least one post-baseline assessment of any efficacy endpoint (clinical or radiological) or a report of death.
PFS was measured from the date of the first dose of study treatment to the date of the first confirmed progression (including clinical progression) or the date of death if a subject died before progression. Per irRC, irPD requires a ≥ 25% increase from nadir in tumor burden at any single time point in two consecutive observations at least 4 weeks apart (Wolchok et al 2009). Subjects who did not experience a PFS event (progression or death) were censored at the date of the last tumor assessment. Subjects with no relevant tumor response assessment were censored at the start date of study treatment.
Outcome measures
| Measure |
Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme
n=3 Participants
Subjects received durvalumab (0.3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 1 mg/kg Durva + 3 mg/kg Treme
n=10 Participants
Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 3 mg/kg Treme
n=3 Participants
Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 1 mg/kg Treme
n=4 Participants
Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Ovarian Cancer
n=18 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Colorectal Cancer
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Non-triple Negative Breast Cancer
n=16 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Renal Cell Carcinoma
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Cervical Cancer
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Median Progression-free Survival Per irRC Based on Kaplan-Meier Product Limit Estimates
|
82 days
Interval 48.0 to 82.0
|
76 days
Interval 34.0 to 1007.0
|
51 days
Interval 49.0 to 401.0
|
42 days
Interval 40.0 to 52.0
|
54 days
Interval 12.0 to 618.0
|
57 days
Interval 32.0 to 559.0
|
57 days
Interval 27.0 to 223.0
|
326 days
Interval 54.0 to 611.0
|
79 days
Interval 32.0 to 617.0
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: The population comprises all subjects who received at least one dose of the durvalumab/tremelimumab combination and had the baseline and at least one post-baseline assessment of any efficacy endpoint (clinical or radiological) or a report of death.
PFS was measured from the date of the first dose of study treatment to the date of the first confirmed progression (including clinical progression) or the date of death if a subject died before progression. Per RECIST 1.1, PD requires a ≥ 20% increase in the sum of the longest diameter of target lesions (Eisenhauer et al 2009). Subjects who did not experience a PFS event (progression or death) were censored at the date of the last tumor assessment. Subjects with no relevant tumor response assessment were censored at the start date of study treatment.
Outcome measures
| Measure |
Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme
n=3 Participants
Subjects received durvalumab (0.3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 1 mg/kg Durva + 3 mg/kg Treme
n=10 Participants
Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 3 mg/kg Treme
n=3 Participants
Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 1 mg/kg Treme
n=4 Participants
Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Ovarian Cancer
n=18 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Colorectal Cancer
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Non-triple Negative Breast Cancer
n=16 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Renal Cell Carcinoma
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Cervical Cancer
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Median Progression-free Survival Per RECIST 1.1 Based on Kaplan-Meier Product Limit Estimates
|
82 days
Interval 48.0 to 251.0
|
76 days
Interval 34.0 to 1007.0
|
51 days
Interval 49.0 to 401.0
|
42 days
Interval 40.0 to 52.0
|
54 days
Interval 12.0 to 618.0
|
57 days
Interval 32.0 to 559.0
|
56 days
Interval 27.0 to 223.0
|
279 days
Interval 50.0 to 555.0
|
58 days
Interval 27.0 to 617.0
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: The population comprises all subjects who received at least one dose of the durvalumab/tremelimumab combination and had the baseline and at least one post-baseline assessment of any efficacy endpoint (clinical or radiological) or a report of death.
All subjects were monitored for survival follow-up at least every 6 months after study completion for up to 3 years after initiation of treatment. Subjects who continued into the Extension part of the study may have been followed for longer than 3 years if they were still receiving treatment. OS was measured from the date of the first dose of study treatment until the recorded date of death. Subjects without a recorded outcome of death were censored at the date of last contact.
Outcome measures
| Measure |
Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme
n=3 Participants
Subjects received durvalumab (0.3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 1 mg/kg Durva + 3 mg/kg Treme
n=10 Participants
Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 3 mg/kg Treme
n=3 Participants
Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 1 mg/kg Treme
n=4 Participants
Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Ovarian Cancer
n=18 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Colorectal Cancer
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Non-triple Negative Breast Cancer
n=16 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Renal Cell Carcinoma
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Cervical Cancer
n=15 Participants
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Median Overall Survival (OS) Based on Kaplan-Meier Product Limit Estimates
|
321 days
Interval 48.0 to 482.0
|
592 days
Interval 44.0 to 1380.0
|
664 days
Interval 76.0 to 1000.0
|
223 days
Interval 120.0 to 873.0
|
460 days
Interval 12.0 to 652.0
|
267 days
Interval 56.0 to 559.0
|
267 days
Interval 35.0 to 589.0
|
462 days
Interval 312.0 to 611.0
|
583 days
Interval 32.0 to 617.0
|
Adverse Events
Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Escalation: 1 mg/kg Durva + 3 mg/kg Treme
Serious events: 5 serious events
Other events: 11 other events
Deaths: 6 deaths
Escalation: 3 mg/kg Durva + 3 mg/kg Treme
Serious events: 4 serious events
Other events: 4 other events
Deaths: 4 deaths
Escalation: 3 mg/kg Durva + 1 mg/kg Treme
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Expansion: Ovarian Cancer
Serious events: 9 serious events
Other events: 19 other events
Deaths: 10 deaths
Expansion: Colorectal Cancer
Serious events: 8 serious events
Other events: 16 other events
Deaths: 11 deaths
Expansion: Non-triple Negative Breast Cancer
Serious events: 8 serious events
Other events: 16 other events
Deaths: 9 deaths
Expansion: Renal Cell Carcinoma
Serious events: 6 serious events
Other events: 16 other events
Deaths: 4 deaths
Expansion: Cervical Cancer
Serious events: 8 serious events
Other events: 15 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme
n=3 participants at risk
Subjects received durvalumab (0.3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 1 mg/kg Durva + 3 mg/kg Treme
n=11 participants at risk
Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 3 mg/kg Treme
n=4 participants at risk
Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 1 mg/kg Treme
n=4 participants at risk
Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Ovarian Cancer
n=19 participants at risk
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Colorectal Cancer
n=16 participants at risk
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Non-triple Negative Breast Cancer
n=16 participants at risk
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Renal Cell Carcinoma
n=16 participants at risk
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Cervical Cancer
n=15 participants at risk
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
3/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
27.3%
3/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
15.8%
3/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Multi-organ failure
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Oedema
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Endocrine disorders
Hypothalamo-pituitary disorder
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
Other adverse events
| Measure |
Escalation: 0.3 mg/kg Durva + 3 mg/kg Treme
n=3 participants at risk
Subjects received durvalumab (0.3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 1 mg/kg Durva + 3 mg/kg Treme
n=11 participants at risk
Subjects received durvalumab (1 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 3 mg/kg Treme
n=4 participants at risk
Subjects received durvalumab (3 mg/kg Q2W for 13 cycles) and tremelimumab (3 mg/kg Q4W for 6 cycles, then Q12W). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Escalation: 3 mg/kg Durva + 1 mg/kg Treme
n=4 participants at risk
Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Ovarian Cancer
n=19 participants at risk
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Colorectal Cancer
n=16 participants at risk
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Non-triple Negative Breast Cancer
n=16 participants at risk
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Renal Cell Carcinoma
n=16 participants at risk
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
Expansion: Cervical Cancer
n=15 participants at risk
Subjects received durvalumab (10 mg/kg Q2W for 13 cycles or 1500 mg Q4W for 12 cycles) and tremelimumab (1 mg/kg or 75 mg Q4W for 4 cycles). Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W.
Durvalumab and tremelimumab were administered as IV infusions over 60 (± 5) minutes, with durvalumab infusions started at least 60 minutes after the end of the tremelimumab infusion on dual dosing days.
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
45.5%
5/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
50.0%
2/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
75.0%
3/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
57.9%
11/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
50.0%
8/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
43.8%
7/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
50.0%
8/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
46.7%
7/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
27.3%
3/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
15.8%
3/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
37.5%
6/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
31.2%
5/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
3/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
72.7%
8/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
50.0%
2/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
42.1%
8/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
4/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
43.8%
7/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
3/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
45.5%
5/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
21.1%
4/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
31.2%
5/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
4/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
31.2%
5/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
5/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
45.5%
5/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
50.0%
2/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
36.8%
7/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
37.5%
6/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
4/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
26.7%
4/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
45.5%
5/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
31.2%
5/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
4/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
5/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
50.0%
2/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
15.8%
3/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
31.2%
5/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
50.0%
2/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
21.1%
4/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
3/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
5/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
27.3%
3/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
21.1%
4/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Oedema peripheral
|
66.7%
2/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
27.3%
3/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
3/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
4/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
54.5%
6/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
15.8%
3/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
27.3%
3/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
15.8%
3/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
21.1%
4/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
4/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
3/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
21.1%
4/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
31.2%
5/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
27.3%
3/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
21.1%
4/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
15.8%
3/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
5/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
45.5%
5/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
15.8%
3/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
21.1%
4/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
36.4%
4/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Chills
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
15.8%
3/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
27.3%
3/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
3/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
27.3%
3/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
26.7%
4/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
15.8%
3/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.8%
3/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
15.8%
3/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Device occlusion
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Early satiety
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
27.3%
3/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Infusion site reaction
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
13.3%
2/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Hydronephrosis
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Swelling
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
10.5%
2/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
12.5%
2/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
50.0%
2/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Irritability
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Oedema
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Thirst
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Reproductive system and breast disorders
Vaginal disorder
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
5.3%
1/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.2%
1/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
6.7%
1/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
18.2%
2/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Paralysis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Tenderness
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Urine output decreased
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Genital herpes
|
33.3%
1/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Facial pain
|
0.00%
0/3 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
9.1%
1/11 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/19 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/16 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/15 • Adverse events (AEs) were documented from informed consent through 90 days after the last study drug dose (regardless of causality to study drug), i.e., during the treatment period, which was up to 15 months for those participating in the Core Study and up to 36 months for those continuing in the Extension. All-cause mortality was collected as a part of survival follow-up for up to 3 years after initiation of treatment, or longer (i.e., up to 48 months) for patients continuing in the Extension.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Phone: (212) 450-1539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60