Trial Outcomes & Findings for Study of Cobimetinib in Participants With Solid Tumors (NCT NCT00467779)
NCT ID: NCT00467779
Last Updated: 2016-08-26
Results Overview
Adverse events (AE) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0. DLT was defined as either of the following occurring during the Study Treatment Period. The occurrence of a drug-related AE that, in the opinion of the cohort review committee (CRC), was of potential clinical significance such that further dose escalation would expose participants in higher dose cohorts to risk of irreversible medical harm or require medical treatment to avoid irreversible medical harm or non-hematologic toxicity * Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment Hematologic toxicity * Grade 4 thrombocytopenia * Grade 4 neutropenia of greater than or equal to (≥) 4 days' duration * Grade 4 neutropenia of any duration with fever or documented infection
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
119 participants
Primary outcome timeframe
Stage 1 and 1A: Days 1 to 28 of Cycle 1
Results posted on
2016-08-26
Participant Flow
Study included following stages: Stage 1, Stage 1A, Stage 2, Stage 2A, and Stage 3. Different participants were recruited in each stage.
Participant milestones
| Measure |
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
Participants received cobimetinib (GDC-0973/XL518) 0.05 milligrams per kilograms (mg/kg) via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 2 Cohort 20 - Cobimetinib 60 mg (Expansion) (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan
Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. In Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
4
|
3
|
3
|
3
|
3
|
6
|
7
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
4
|
3
|
3
|
3
|
3
|
5
|
7
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1A
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
8
|
6
|
0
|
0
|
|
Stage 1A
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1A
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
8
|
6
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
21
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
21
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2A
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
22
|
0
|
|
Stage 2A
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Stage 2A
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
21
|
0
|
|
Stage 3
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
20
|
|
Stage 3
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Stage 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
17
|
Reasons for withdrawal
| Measure |
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
Participants received cobimetinib (GDC-0973/XL518) 0.05 milligrams per kilograms (mg/kg) via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 2 Cohort 20 - Cobimetinib 60 mg (Expansion) (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan
Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. In Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Disease Progression
|
2
|
2
|
2
|
3
|
2
|
2
|
4
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Unspecified Reason
|
1
|
0
|
1
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1A
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Stage 1A
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Stage 1A
Disease Progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
5
|
2
|
0
|
0
|
|
Stage 1A
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1A
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
|
Stage 1A
Unspecified Reason
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Stage 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Disease Progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Unspecified Reason
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2A
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Stage 2A
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Stage 2A
Disease Progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
0
|
|
Stage 2A
Unspecified Reason
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
|
Stage 2A
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Stage 3
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Stage 3
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Stage 3
Disease Progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
|
Stage 3
Unspecified Reason
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
Baseline Characteristics
Study of Cobimetinib in Participants With Solid Tumors
Baseline characteristics by cohort
| Measure |
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=4 Participants
Participants received cobimetinib 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=3 Participants
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=6 Participants
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=7 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=7 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 2 Cohort 20 - Cobimetinib 60 mg (Expansion) (21/7)
n=21 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
n=3 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
n=3 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
n=8 Participants
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
n=6 Participants
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)
n=22 Participants
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan
n=20 Participants
Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. In Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 11.52 • n=99 Participants
|
60.7 years
STANDARD_DEVIATION 19.73 • n=107 Participants
|
51.3 years
STANDARD_DEVIATION 6.35 • n=206 Participants
|
66.0 years
STANDARD_DEVIATION 10.82 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 9.61 • n=31 Participants
|
62.0 years
STANDARD_DEVIATION 12.38 • n=30 Participants
|
63.9 years
STANDARD_DEVIATION 5.87 • n=3 Participants
|
54.4 years
STANDARD_DEVIATION 8.40 • n=6 Participants
|
59.7 years
STANDARD_DEVIATION 13.08 • n=114 Participants
|
52.7 years
STANDARD_DEVIATION 13.20
|
49.7 years
STANDARD_DEVIATION 21.08 • n=19 Participants
|
55.1 years
STANDARD_DEVIATION 13.46 • n=4 Participants
|
61.5 years
STANDARD_DEVIATION 13.61 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 11.45 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 15.60 • n=3 Participants
|
59.1 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
11 Participants
n=114 Participants
|
1 Participants
|
3 Participants
n=19 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=3 Participants
|
59 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
2 Participants
|
0 Participants
n=19 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=3 Participants
|
60 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Stage 1 and 1A: Days 1 to 28 of Cycle 1Population: Safety population; Stages 1 and 1A participants only.
Adverse events (AE) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0. DLT was defined as either of the following occurring during the Study Treatment Period. The occurrence of a drug-related AE that, in the opinion of the cohort review committee (CRC), was of potential clinical significance such that further dose escalation would expose participants in higher dose cohorts to risk of irreversible medical harm or require medical treatment to avoid irreversible medical harm or non-hematologic toxicity * Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment Hematologic toxicity * Grade 4 thrombocytopenia * Grade 4 neutropenia of greater than or equal to (≥) 4 days' duration * Grade 4 neutropenia of any duration with fever or documented infection
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=4 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=3 Participants
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=6 Participants
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=7 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=7 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
n=3 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
n=3 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
n=8 Participants
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
n=6 Participants
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1 and 1A: Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Stage 1: Days 1 to 28 of Cycle 1Population: Safety population; Stage 1 participants only.
AEs were graded according to the NCI-CTCAE v3.0. A DLT was determined from clinical findings during the Study Treatment Period (Cycle 1, Days 1). MTD was defined as the dose at which no DLTs were observed. DLT was defined as either of the following occurring during the Study Treatment Period. The occurrence of a drug-related AE that, in the opinion of the CRC, was of potential clinical significance such that further dose escalation would expose participants in higher dose cohorts to risk of irreversible medical harm or require medical treatment to avoid irreversible medical harm or non-hematologic toxicity * Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment Hematologic toxicity * Grade 4 thrombocytopenia * Grade 4 neutropenia of greater than or equal to (≥) 4 days' duration * Grade 4 neutropenia of any duration with fever or documented infection
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=36 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Maximum Tolerated Dose (MTD) of Cobimetinib in 21/7 Schedule
|
—
|
—
|
—
|
60 milligrams (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Stage 1A: Days 1 to 28 of Cycle 1Population: Safety population; Stage 1A participants only.
AEs were graded according to NCI-CTCAE v3.0. A DLT was the basis for determining MTD in Stage 1A participants. The participants of Stage 1A are dose-escalation cohorts, starting at the MTD of the 21/7 schedule, were treated on a 14/14 schedule to determine the MTD. A DLT was defined as either of the following occurring during the Study Treatment Period: Occurrence of a drug-related AE that, in the opinion of the CRC, was of potential clinical significance such that further dose escalation would expose participants to risk of irreversible medical harm; Nonhematologic toxicity: Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment; Hematologic toxicity: Grade 4 thrombocytopenia. Grade 4 neutropenia of more than 4 days' duration; Grade 4 neutropenia of any duration with fever or documented infection. AEs (Grade 3 or higher) for which a clinical cause unrelated to cobimetinib was evident was not considered DLTs.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=20 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1A: MTD of Cobimetinib in 14/14 Schedule
|
—
|
—
|
—
|
100 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Stage 1: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1 and pre-dose on Cycle 1 Day 2Population: Safety population; Stage 1 participants only.
Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib on Day 1, Cycle 1 in Stage 1 and was measured as nanograms per milliliter (ng/mL).
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=4 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=3 Participants
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=6 Participants
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=7 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=7 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Maximum Observed Concentration (Cmax) of Cobimetinib at Day 1, Cycle 1
|
6.92 ng/mL
Standard Deviation 3.8
|
18.3 ng/mL
Standard Deviation 13.0
|
18.8 ng/mL
Standard Deviation 5.1
|
4.51 ng/mL
Standard Deviation 5.8
|
30.8 ng/mL
Standard Deviation 69.0
|
71.7 ng/mL
Standard Deviation 57.0
|
163.0 ng/mL
Standard Deviation 79.0
|
261.0 ng/mL
Standard Deviation 110.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2Population: Safety population; Stage 1 participants only.
The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samples. AUC is measured as hours times nanograms per milliliter (h\*ng/mL).
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=4 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=3 Participants
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=6 Participants
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=7 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=7 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Area Under the Plasma Cobimetinib Concentration Curve From Time 0 to 24 Hours (AUC 0-24) Day 1, Cycle 1
|
68.0 h*ng/mL
Standard Deviation 47.0
|
203.0 h*ng/mL
Standard Deviation 130.0
|
242.0 h*ng/mL
Standard Deviation 64.0
|
56.2 h*ng/mL
Standard Deviation 65.0
|
440.0 h*ng/mL
Standard Deviation 870.0
|
785.0 h*ng/mL
Standard Deviation 560.0
|
1620.0 h*ng/mL
Standard Deviation 830.0
|
3060.0 h*ng/mL
Standard Deviation 950.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1 and pre-dose on Cycle 1 Day 2Population: Safety population; Stage 1 participants only.
Tmax is defined as the time to reach Cmax during stage 1 at Day 1 Cycle 1.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=4 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=3 Participants
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=6 Participants
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=7 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=7 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Time to Maximum Concentration (Tmax) of Cobimetinib at Day 1, Cycle 1
|
1.0 hours
Interval 1.0 to 2.0
|
1.5 hours
Interval 1.0 to 1.5
|
3.0 hours
Interval 1.0 to 4.0
|
2.0 hours
Interval 2.0 to 8.0
|
4.0 hours
Interval 2.0 to 4.0
|
2.5 hours
Interval 1.5 to 6.0
|
2.0 hours
Interval 1.0 to 4.0
|
2.0 hours
Interval 1.5 to 2.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)Population: Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Tmax is defined as the time to reach Cmax during stage 1 in steady state. Steady state was reached when overall intake of cobimetinib was in dynamic equilibrium with its elimination.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=3 Participants
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=6 Participants
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=7 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=7 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Tmax of Cobimetinib at Steady State
|
1.0 hours
Interval 1.0 to 2.0
|
2.25 hours
Interval 1.5 to 3.0
|
4.0 hours
Interval 3.0 to 4.0
|
4.0 hours
Interval 2.0 to 4.0
|
3.0 hours
Interval 3.0 to 3.0
|
2.0 hours
Interval 1.5 to 3.0
|
3.0 hours
Interval 1.5 to 4.0
|
2.5 hours
Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)Population: Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
The area under the AUC0-24 for steady state in stage 1 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=2 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=1 Participants
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=5 Participants
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=4 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=6 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: AUC 0-24 of Cobimetinib at Steady State
|
288.0 h*ng/mL
Standard Deviation 200.0
|
411.0 h*ng/mL
Standard Deviation 199.0
|
763.0 h*ng/mL
Standard Deviation 168.0
|
202.0 h*ng/mL
Standard Deviation 158.0
|
886.0 h*ng/mL
|
5370.0 h*ng/mL
Standard Deviation 4600.0
|
6250.0 h*ng/mL
Standard Deviation 3540.0
|
10500.0 h*ng/mL
Standard Deviation 10500.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)Population: Safety Population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=2 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=1 Participants
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=5 Participants
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=4 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=6 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: AUC 0-24/D of Cobimetinib at Steady State
|
34 ng*hr/mL/mg
Standard Deviation 16.9
|
28.2 ng*hr/mL/mg
Standard Deviation 8.43
|
76.3 ng*hr/mL/mg
Standard Deviation 16.8
|
62.4 ng*hr/mL/mg
Standard Deviation 36.3
|
44.3 ng*hr/mL/mg
|
134 ng*hr/mL/mg
Standard Deviation 115
|
104 ng*hr/mL/mg
Standard Deviation 59.1
|
132 ng*hr/mL/mg
Standard Deviation 131
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1, Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)Population: Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Accumulation Ratio: AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=2 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=1 Participants
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=4 Participants
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=4 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=5 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Accumulation Ratio of Cobimetinib at Steady State
|
3.66 ratio
Standard Deviation 0.901
|
2.65 ratio
Standard Deviation 0.886
|
3.23 ratio
Standard Deviation 1.03
|
3.56 ratio
Standard Deviation 1.76
|
2.96 ratio
|
3.61 ratio
Standard Deviation 2.27
|
2.87 ratio
Standard Deviation 0.787
|
3.26 ratio
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)Population: Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=2 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=1 Participants
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=5 Participants
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=4 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=6 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Apparent Clearance of Cobimetinib at Steady State
|
34.0 Liters per hour (L/hr)
Standard Deviation 14.2
|
37.1 Liters per hour (L/hr)
Standard Deviation 11.1
|
13.5 Liters per hour (L/hr)
Standard Deviation 2.71
|
22.4 Liters per hour (L/hr)
Standard Deviation 17.2
|
22.6 Liters per hour (L/hr)
|
14.0 Liters per hour (L/hr)
Standard Deviation 10.1
|
11.8 Liters per hour (L/hr)
Standard Deviation 5.71
|
11.6 Liters per hour (L/hr)
Standard Deviation 5.42
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)Population: Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
t1/2 is the half-life of cobimetinib measured over the terminal phase by noncompartmental analysis in stage 1 in steady state.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=2 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=1 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=1 Participants
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=5 Participants
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=4 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=5 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Half-Life (t1/2) of Cobimetinib at Steady State
|
64.0 hours
Interval 51.5 to 73.0
|
47.8 hours
Interval 46.5 to 49.1
|
66.0 hours
Interval 34.0 to 67.5
|
80.0 hours
Interval 80.0 to 80.0
|
50.5 hours
Interval 50.5 to 50.5
|
41.3 hours
Interval 34.2 to 62.4
|
51.3 hours
Interval 23.1 to 61.4
|
60.0 hours
Interval 33.5 to 65.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)Population: Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 1 and was measured at steady state in ng/mL.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=2 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=1 Participants
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=5 Participants
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=4 Participants
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=6 Participants
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Cmax of Cobimetinib at Steady State
|
19.8 ng/mL
Standard Deviation 15.2
|
28.7 ng/mL
Standard Deviation 8.63
|
53.0 ng/mL
Standard Deviation 5.4
|
13.5 ng/mL
Standard Deviation 9.53
|
54.7 ng/mL
|
341.0 ng/mL
Standard Deviation 244.0
|
401.0 ng/mL
Standard Deviation 214.0
|
641.0 ng/mL
Standard Deviation 514.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2Population: Safety population; Stage 1A participants only.
Tmax is defined as the time to reach Cmax during stage 1A at Day 1.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=8 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=6 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1A: Tmax of Cobimetinib at Cycle 1 Day 1
|
4.0 hours
Interval 2.0 to 24.0
|
3.5 hours
Interval 1.5 to 6.0
|
2.5 hours
Interval 2.0 to 4.0
|
3.0 hours
Interval 1.5 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2Population: Safety population; Stage 1A participants only.
Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib on on Day 1 in Stage 1A and was measured as ng/mL.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=8 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=6 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1A: Cmax of Cobimetinib at Cycle 1 Day 1
|
167.0 ng/mL
Standard Deviation 63.0
|
258.0 ng/mL
Standard Deviation 140.0
|
533.0 ng/mL
Standard Deviation 347.0
|
78.4 ng/mL
Standard Deviation 88.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2Population: Safety population; Stage 1A participants only.
AUC0-24 for stage 1A was calculated on Day 1 with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=8 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=6 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1A: AUC 0-24 of Cobimetinib at Cycle 1 Day 1
|
2130 h*ng/mL
Standard Deviation 70.1
|
4020 h*ng/mL
Standard Deviation 2000
|
7190 h*ng/mL
Standard Deviation 3640
|
1140 h*ng/mL
Standard Deviation 1150
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)Population: Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.
t1/2 is the half-life of cobimetinib measured over the terminal phase by noncompartmental analysis in stage 1A in steady state.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=1 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=1 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=1 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1A: t1/2 of Cobimetinib at Steady State
|
44.1 hours
Interval 44.1 to 44.1
|
51.6 hours
Interval 48.1 to 71.1
|
47.7 hours
Interval 47.7 to 47.7
|
59.4 hours
Interval 59.4 to 59.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)Population: Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Tmax is defined as the time to reach Cmax during stage 1A in steady state.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=5 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1A: Tmax of Cobimetinib at Steady State
|
2.0 hours
Interval 2.0 to 6.0
|
3 hours
Interval 1.5 to 4.0
|
6 hours
Interval 2.0 to 6.0
|
2.0 hours
Interval 1.5 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)Population: Safety population; Stage 1A participants only. Number pf participants analyzed = participants who were evaluable for this outcome.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=5 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1A: Apparent Clearance of Cobimetinib at Steady State
|
14.9 L/hr
Standard Deviation 8.33
|
21.9 L/hr
Standard Deviation 20.3
|
6.9 L/hr
Standard Deviation 3.22
|
25.1 L/hr
Standard Deviation 13.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)Population: Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Accumulation Ratio: AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=5 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1A: Accumulation Ratio of Cobimetinib at Steady State
|
3.14 ratio
Standard Deviation 1.77
|
2.6 ratio
Standard Deviation 2.32
|
5.15 ratio
Standard Deviation 2.08
|
2.32 ratio
Standard Deviation 0.448
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)Population: Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.
The area under the AUC0-24 for steady state in stage 1A was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=5 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1A: AUC 0-24 of Cobimetinib at Steady State
|
6740.0 h*ng/mL
Standard Deviation 3830.0
|
11500.0 h*ng/mL
Standard Deviation 10500.0
|
21500.0 h*ng/mL
Standard Deviation 11300.0
|
2990.0 h*ng/mL
Standard Deviation 1750.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)Population: Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.
AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=5 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1A: AUC 0-24/D of Cobimetinib at Steady State
|
84.2 ng*hr/mL/mg
Standard Deviation 47.8
|
115.0 ng*hr/mL/mg
Standard Deviation 105.0
|
172.0 ng*hr/mL/mg
Standard Deviation 90.4
|
49.8 ng*hr/mL/mg
Standard Deviation 29.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)Population: Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 1A and was measured in steady state as ng/mL.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=5 Participants
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 Participants
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=3 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1A: Cmax of Cobimetinib at Steady State
|
494.0 ng/mL
Standard Deviation 175.0
|
640.0 ng/mL
Standard Deviation 511.0
|
1160.0 ng/mL
Standard Deviation 540.0
|
180.0 ng/mL
Standard Deviation 101.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2Population: Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 2 and was measured in ng/mL.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=19 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Cmax of Cobimetinib at Cycle 1 Day 1
|
—
|
—
|
—
|
184.0 ng/mL
Standard Deviation 160.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2Population: Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
The area under the AUC0-24 on Day 1 in stage 2 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=19 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2:AUC 0-24 of Cobimetinib at Cycle 1 Day 1
|
—
|
—
|
—
|
3060.0 h*ng/mL
Standard Deviation 2110.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2Population: Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Tmax is defined as the time to reach Cmax during stage 2 on Day 1.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=19 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Tmax of Cobimetinib at Cycle 1 Day 1
|
—
|
—
|
—
|
3.0 hours
Interval 1.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28Population: Safety population; Stage 2 participants only; Number of participants analyzed = participants who were evaluable for this outcome.
Tmax is defined as the time to reach Cmax during stage 2 in steady state.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=13 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Tmax of Cobimetinib at Steady State
|
—
|
—
|
—
|
4.0 hours
Interval 1.5 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28Population: Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
The area under the AUC0-24 for steady state in stage 2 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=13 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: AUC 0-24 of Cobimetinib at Steady State
|
—
|
—
|
—
|
10200.0 h*ng/mL
Standard Deviation 5630.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28Population: Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=13 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: AUC 0-24/D of Cobimetinib at Steady State
|
—
|
—
|
—
|
102.0 h*ng/mL
Standard Deviation 56.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28Population: Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Accumulation ratio is AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=13 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Accumulation Ratio of Cobimetinib at Steady State
|
—
|
—
|
—
|
2.5 ratio
Standard Deviation 0.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28Population: Safety population
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=13 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Apparent Clearance of Cobimetinib at Steady State
|
—
|
—
|
—
|
9.8 L/hr
Standard Deviation 9.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28Population: Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.
T1/2 half-life of cobimetinib measured over the terminal phase by noncompartmental analysis.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=13 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2:Half-Life of Cobimetinib at Steady State
|
—
|
—
|
—
|
53.4 hours
Interval 45.3 to 68.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28Population: Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.
AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=15 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2A: AUC 0-24/D of Cobimetinib at Steady State
|
—
|
—
|
—
|
84.8 h*ng/mL
Standard Deviation 52.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28Population: Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Accumulation Ratio AUC0-24 is ratio of AUC on Day 20: Day 1.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=15 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2A: Accumulation Ratio of Cobimetinib at Steady State
|
—
|
—
|
—
|
2.3 ratio
Standard Deviation 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28Population: Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Apparent clearance is the plasma clearance of absorbed drug.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=15 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2A: Apparent Clearance of Cobimetinib at Steady State
|
—
|
—
|
—
|
11.8 L/hr
Standard Deviation 5.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28Population: Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=15 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2A: Half-Life of Cobimetinib at Steady State
|
—
|
—
|
—
|
42.7 hours
Interval 27.8 to 69.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28Population: Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Tmax is defined as the time to reach Cmax during stage 2A in steady state.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=15 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2A: Tmax of Cobimetinib at Steady State
|
—
|
—
|
—
|
3.0 hours
Interval 1.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28Population: Analysis population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.
Cmax is the maximum plasma concentration achieved following the Day 20 dose in Stage 2A.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=15 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2A: Cmax of Cobimetinib at Steady State
|
—
|
—
|
—
|
315.0 ng/mL
Standard Deviation 220.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1Population: Safety population; Stage 3 participants only. n=number of participants analyzed for specified category.
Cmax is defined as maximum observed plasma concentration and was determined both in the presence (Cycle 1 Day 15) and absence of cobimetinib (Cycle 1 Day 1).
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=20 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage III: Cmax of Dextromethorphan
With cobimetinib - Cycle 1 Day 15(n=17)
|
—
|
—
|
—
|
3.44 ng/mL
Standard Deviation 150.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage III: Cmax of Dextromethorphan
Without cobimetinib - Cycle 1 Day 1 (n=20)
|
—
|
—
|
—
|
3.16 ng/mL
Standard Deviation 273.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1Population: Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.
AUC0-24 is the area under the plasma drug concentration curve over a 24-hour sampling interval and was determined both in presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=19 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage III: AUC 0-24 of Dextromethorphan
With cobimetinib - Cycle 1 Day 1 (n=17)
|
—
|
—
|
—
|
24.8 h*ng/mL
Standard Deviation 180.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage III: AUC 0-24 of Dextromethorphan
Without cobimetinib - Cycle 1 Day1 (n=19)
|
—
|
—
|
—
|
25.8 h*ng/mL
Standard Deviation 240
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1Population: Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.
AUC0-inf is AUC from time 0 to infinity and was calculated both in presence Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=19 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage III: AUC 0-inf of Dextromethorphan
With cobimetinib - Cycle 1 Day 15 (n=13)
|
—
|
—
|
—
|
29.1 h*ng/mL
Standard Deviation 250.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage III: AUC 0-inf of Dextromethorphan
Without cobimetinib - Cycle 1 Day1 (n=19)
|
—
|
—
|
—
|
18.9 h*ng/mL
Standard Deviation 124.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1Population: Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.
Cmax is the maximum observed plasma concentration and was calculated both in the presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=20 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage III: Cmax of Midazolam
With cobimetinib - Cycle 1 Day15 (n=17)
|
—
|
—
|
—
|
11.5 ng/mL
Standard Deviation 64.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage III: Cmax of Midazolam
Without cobimetinib - Cycle 1 Day 1(n=20)
|
—
|
—
|
—
|
10.9 ng/mL
Standard Deviation 79.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1Population: Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.
AUC0-24 is the area under the plasma drug concentration curve over a 24-hour sampling interval and was calculated both in the presence (Cycle 1 Day 15) and absence (CXycle 1 Day 1) of cobimetinib.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=14 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage III: AUC0-24 of Midazolam
With cobimetinib - Cycle 1 Day 15 (n=14)
|
—
|
—
|
—
|
33.0 h*ng/mL
Standard Deviation 74.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage III: AUC0-24 of Midazolam
Without cobimetinib - Cycle 1 Day 1 (n=11)
|
—
|
—
|
—
|
33.4 h*ng/mL
Standard Deviation 88.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1Population: Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.
AUC0-inf is the AUC from time 0 to infinity and was calculated both in the presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.
Outcome measures
| Measure |
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=19 Participants
Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment \[21/7 schedule\]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage III: AUC0-inf of Midazolam
With cobimetinib - Cycle 1 Day 15 (n=17)
|
—
|
—
|
—
|
34.9 h*ng/mL
Standard Deviation 77.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage III: AUC0-inf of Midazolam
Without cobimetinib Cycle 1 Day 1 (n=19)
|
—
|
—
|
—
|
35.7 h*ng/mL
Standard Deviation 91.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Stage 2 Cohort 20 - Cobimetinib 60 mg (Expansion) (21/7)
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)
Serious events: 11 serious events
Other events: 21 other events
Deaths: 0 deaths
Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan
Serious events: 8 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=4 participants at risk
Participants received cobimetinib 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 participants at risk
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=3 participants at risk
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 participants at risk
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=3 participants at risk
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=6 participants at risk
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=7 participants at risk
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=7 participants at risk
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 2 Cohort 20 - Cobimetinib 60 mg (Expansion) (21/7)
n=21 participants at risk
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
n=3 participants at risk
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
n=3 participants at risk
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
n=8 participants at risk
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
n=6 participants at risk
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)
n=22 participants at risk
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan
n=20 participants at risk
Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period. Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Ileus
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Chest pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Fatigue
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.1%
2/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Generalised oedema
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Hepatobiliary disorders
Bile duct obstruction
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Troponin increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Surgical and medical procedures
Pleurodesis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
Other adverse events
| Measure |
Stage 1 Cohort 01 - Cobimetinib 0.05 mg/kg (21/7)
n=4 participants at risk
Participants received cobimetinib 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 02 - Cobimetinib 0.10 mg/kg (21/7)
n=3 participants at risk
Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 03 - Cobimetinib 0.20 mg/kg (21/7)
n=3 participants at risk
Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)
n=3 participants at risk
Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)
n=3 participants at risk
Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)
n=6 participants at risk
Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 07 - Cobimetinib 60 mg (21/7)
n=7 participants at risk
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)
n=7 participants at risk
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 2 Cohort 20 - Cobimetinib 60 mg (Expansion) (21/7)
n=21 participants at risk
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)
n=3 participants at risk
Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment \[14/14 schedule\]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)
n=3 participants at risk
Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)
n=8 participants at risk
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)
n=6 participants at risk
Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)
n=22 participants at risk
Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
|
Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan
n=20 participants at risk
Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period. Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
3/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.1%
2/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.1%
2/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.5%
2/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
50.0%
3/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.1%
2/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
13.6%
3/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.1%
2/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Eye disorders
Macular degeneration
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Eye disorders
Cataract
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Eye disorders
Ocular icterus
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Eye disorders
Uveitis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
3/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
13.6%
3/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Hordeolum
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Gastroenteritis viral
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Groin infection
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Nail bed infection
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Peritonitis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Syphilis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
13.6%
3/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
30.0%
6/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.1%
2/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.5%
2/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
19.0%
4/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Vascular disorders
Bloody discharge
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Vascular disorders
Thrombosis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.1%
2/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.5%
2/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Reproductive system and breast disorders
Vulvovaginal erythema
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Hepatobiliary disorders
Jaundice
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Cardiac disorders
Atrial fibrillation
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
57.1%
4/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
71.4%
5/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
6/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
62.5%
5/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
22.7%
5/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
20.0%
4/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Hyperreflexia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
50.0%
3/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
57.1%
4/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
57.1%
4/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
61.9%
13/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
75.0%
6/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
100.0%
6/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
77.3%
17/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
60.0%
12/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
42.9%
3/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
42.9%
3/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
7/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
75.0%
6/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
40.9%
9/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
20.0%
4/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
42.9%
3/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
23.8%
5/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
50.0%
4/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
54.5%
12/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
5/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.5%
2/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
62.5%
5/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
40.9%
9/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
15.0%
3/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
42.9%
3/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
3/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
27.3%
6/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
20.0%
4/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
3/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.1%
2/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
20.0%
4/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.5%
2/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.5%
2/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
3/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Fatigue
|
50.0%
2/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
57.1%
4/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
42.9%
3/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
47.6%
10/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
75.0%
6/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
63.6%
14/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
40.0%
8/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
50.0%
3/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
71.4%
5/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
71.4%
5/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
61.9%
13/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
50.0%
4/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
50.0%
3/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
50.0%
11/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
30.0%
6/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
42.9%
3/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.1%
2/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.5%
2/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
13.6%
3/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
5/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
15.0%
3/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Facial wasting
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Papule
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Pyrexia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
13.6%
3/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Oedema
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
13.6%
3/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Asthenia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Chills
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.1%
2/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Face oedema
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.5%
2/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Chest pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Malaise
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Feeling hot
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Early satiety
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Hypothermia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Injection site pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Irritability
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Localised oedema
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
General disorders
Tenderness
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
23.8%
5/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
31.8%
7/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
30.0%
6/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
6/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
40.9%
9/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
50.0%
3/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.5%
2/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
22.7%
5/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.5%
2/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
20.0%
4/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.5%
2/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
42.9%
3/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
3/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
37.5%
3/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
22.7%
5/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
15.0%
3/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.1%
2/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Hypoaesthesia
|
25.0%
1/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Convulsion
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Drug withdrawal headache
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Loss of proprioception
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.5%
2/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
13.6%
3/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
28.6%
2/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
37.5%
3/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
25.0%
2/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
20.0%
4/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
2/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Critical illness myopathy
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
3/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
37.5%
3/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.1%
2/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
3/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
66.7%
2/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
20.0%
4/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
15.0%
3/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
10.0%
2/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Weight decreased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.8%
1/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
9.1%
2/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
33.3%
1/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Weight increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
4.5%
1/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Ammonia increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
16.7%
1/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Blood pressure increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Blood urine present
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
14.3%
1/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Electrocardiogram QRS complex abnormal
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Haemoglobin
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Platelet count increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Protein total decreased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
5.0%
1/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
|
Investigations
Waist circumference increased
|
0.00%
0/4 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/7 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/21 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/3 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
12.5%
1/8 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/6 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/22 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
0.00%
0/20 • AEs were recorded from the Day 1 of treatment period until the 30 plus or minus 4 days after the last treatment (up to approximately 6 years) .
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER