Trial Outcomes & Findings for Study of RP-6306 With Gemcitabine in Advanced Solid Tumors (NCT NCT05147272)
NCT ID: NCT05147272
Last Updated: 2025-12-05
Results Overview
Incidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs)
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
67 participants
Primary outcome timeframe
Start of treatment to 30 days post last dose. up to 1.5 years
Results posted on
2025-12-05
Participant Flow
Participant milestones
| Measure |
Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
40 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
80 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine
40 mg QD oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine
40 mg BID oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine
40 mg BID oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine
40 mg BID oral (PO) lunresertib continuously daily in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
40 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day
60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8
80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
120 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
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Overall Study
STARTED
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1
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7
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4
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4
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10
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8
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5
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5
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4
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4
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6
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4
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3
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2
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Overall Study
COMPLETED
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0
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2
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0
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0
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5
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3
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0
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2
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0
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3
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2
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0
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1
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0
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Overall Study
NOT COMPLETED
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1
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5
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4
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4
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5
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5
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5
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3
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4
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1
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4
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4
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2
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of RP-6306 With Gemcitabine in Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
n=1 Participants
40 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
n=7 Participants
80 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine
n=4 Participants
40 mg QD oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine
n=4 Participants
40 mg BID oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine
n=10 Participants
40 mg BID oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine
n=8 Participants
40 mg BID oral (PO) lunresertib continuously daily in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
n=5 Participants
120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
n=5 Participants
120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
n=4 Participants
40 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
n=4 Participants
60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day
n=6 Participants
60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
n=4 Participants
80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8
n=3 Participants
80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
n=2 Participants
120 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Age, Customized
Age (years)
|
66 years
STANDARD_DEVIATION 0 • n=37 Participants
|
59.1 years
STANDARD_DEVIATION 8.53 • n=37 Participants
|
71.0 years
STANDARD_DEVIATION 4.69 • n=74 Participants
|
61 years
STANDARD_DEVIATION 10.85 • n=267 Participants
|
61.4 years
STANDARD_DEVIATION 12.58 • n=272 Participants
|
62.1 years
STANDARD_DEVIATION 10.69 • n=6 Participants
|
62.4 years
STANDARD_DEVIATION 10.64 • n=36 Participants
|
58.6 years
STANDARD_DEVIATION 6.73 • n=18 Participants
|
66.0 years
STANDARD_DEVIATION 10.86 • n=1946 Participants
|
65.3 years
STANDARD_DEVIATION 5.19 • n=106 Participants
|
62.5 years
STANDARD_DEVIATION 10.72 • n=6 Participants
|
54.8 years
STANDARD_DEVIATION 4.58 • n=6 Participants
|
75.0 years
STANDARD_DEVIATION 0.71 • n=6 Participants
|
67.5 years
STANDARD_DEVIATION 9.59 • n=8 Participants
|
62.6 years
STANDARD_DEVIATION 10.10 • n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=37 Participants
|
7 Participants
n=37 Participants
|
3 Participants
n=74 Participants
|
3 Participants
n=267 Participants
|
8 Participants
n=272 Participants
|
8 Participants
n=6 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=18 Participants
|
3 Participants
n=1946 Participants
|
4 Participants
n=106 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=8 Participants
|
57 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=74 Participants
|
1 Participants
n=267 Participants
|
2 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=1946 Participants
|
0 Participants
n=106 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
10 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=1946 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=37 Participants
|
6 Participants
n=37 Participants
|
4 Participants
n=74 Participants
|
4 Participants
n=267 Participants
|
10 Participants
n=272 Participants
|
7 Participants
n=6 Participants
|
5 Participants
n=36 Participants
|
3 Participants
n=18 Participants
|
2 Participants
n=1946 Participants
|
3 Participants
n=106 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=8 Participants
|
59 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=18 Participants
|
1 Participants
n=1946 Participants
|
1 Participants
n=106 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Start of treatment to 30 days post last dose. up to 1.5 yearsIncidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs)
Outcome measures
| Measure |
Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
n=1 Participants
40 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
n=7 Participants
80 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine
n=4 Participants
40 mg QD oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine
n=4 Participants
40 mg BID oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine
n=10 Participants
40 mg BID oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine
n=8 Participants
40 mg BID oral (PO) lunresertib continuously daily in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
n=5 Participants
120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
n=5 Participants
120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
n=4 Participants
40 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
n=4 Participants
60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day
n=6 Participants
60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
n=4 Participants
80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8
n=3 Participants
80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
n=2 Participants
120 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients With of Treatment-related Adverse Event Data Per CTCAE v5.0 Criteria to Determine Safety and Tolerability of RP-6306 in Combination With Gemcitabine.
|
0 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: During 21 days from the initiation of the study treatment (C1D1)Evaluation of dose-limiting toxicities (DLTs) at or below a frequency of 25%
Outcome measures
| Measure |
Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
n=1 Participants
40 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
n=6 Participants
80 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine
n=3 Participants
40 mg QD oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine
n=3 Participants
40 mg BID oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine
n=10 Participants
40 mg BID oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine
n=7 Participants
40 mg BID oral (PO) lunresertib continuously daily in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
n=3 Participants
120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
n=4 Participants
120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
n=4 Participants
40 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
n=3 Participants
60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day
n=4 Participants
60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
n=3 Participants
80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8
n=3 Participants
80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
n=2 Participants
120 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Dose Limiting Toxicities, as Defined Per Protocol, That Occur During the First Cycle (21 Days) of Treatment at Each Dose Level
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
Serious events: 3 serious events
Other events: 7 other events
Deaths: 5 deaths
Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine
Serious events: 5 serious events
Other events: 10 other events
Deaths: 2 deaths
Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine
Serious events: 3 serious events
Other events: 8 other events
Deaths: 3 deaths
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
Serious events: 1 serious events
Other events: 5 other events
Deaths: 4 deaths
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
n=1 participants at risk
40 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
n=7 participants at risk
80 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine
n=4 participants at risk
40 mg QD oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine
n=4 participants at risk
40 mg BID oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine
n=10 participants at risk
40 mg BID oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine
n=8 participants at risk
40 mg BID oral (PO) lunresertib continuously daily in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
n=5 participants at risk
120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
n=5 participants at risk
120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
n=4 participants at risk
40 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
n=4 participants at risk
60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day
n=6 participants at risk
60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
n=4 participants at risk
80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8
n=3 participants at risk
80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
n=2 participants at risk
120 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
General disorders
Fatigue
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Infections and infestations
Pyelonephritis fungal
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Small intestinal Obstruction
|
100.0%
1/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
2/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
Other adverse events
| Measure |
Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
n=1 participants at risk
40 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine
n=7 participants at risk
80 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine
n=4 participants at risk
40 mg QD oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine
n=4 participants at risk
40 mg BID oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine
n=10 participants at risk
40 mg BID oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine
n=8 participants at risk
40 mg BID oral (PO) lunresertib continuously daily in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
n=5 participants at risk
120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
n=5 participants at risk
120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine
n=4 participants at risk
40 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine
n=4 participants at risk
60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day
n=6 participants at risk
60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
n=4 participants at risk
80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8
n=3 participants at risk
80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8
n=2 participants at risk
120 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
5/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
4/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
100.0%
2/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
4/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
37.5%
3/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
100.0%
2/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
30.0%
3/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
37.5%
3/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
60.0%
3/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
37.5%
3/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
2/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
71.4%
5/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
5/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
62.5%
5/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
80.0%
4/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
100.0%
5/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
66.7%
4/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
66.7%
2/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
100.0%
2/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
71.4%
5/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
4/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
37.5%
3/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
66.7%
4/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
66.7%
2/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
100.0%
2/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
57.1%
4/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
2/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
60.0%
3/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
4/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
2/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
30.0%
3/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
2/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
2/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
General disorders
Fatigue
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
42.9%
3/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
5/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
87.5%
7/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
100.0%
5/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
80.0%
4/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
100.0%
4/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
3/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
66.7%
2/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
4/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
General disorders
Chills
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
General disorders
Influenza like illness
|
100.0%
1/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
2/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
General disorders
Non-cardiac chest pain
|
100.0%
1/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
General disorders
Pain
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Infections and infestations
Candida infection
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
2/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
2/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
100.0%
2/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
2/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
2/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
2/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
2/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
2/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
2/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
30.0%
3/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Investigations
Blood lactate dehydrogenase
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
1/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
30.0%
3/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
37.5%
3/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
2/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
30.0%
3/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
37.5%
3/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
42.9%
3/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
2/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
2/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
2/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
100.0%
2/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
2/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
4/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
2/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
40.0%
2/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
2/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
100.0%
1/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
42.9%
3/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
2/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
60.0%
3/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
30.0%
3/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
60.0%
3/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
37.5%
3/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
2/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
12.5%
1/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
10.0%
1/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
1/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
20.0%
1/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Start of treatment to 30 days post last dose up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
50.0%
5/10 • Start of treatment to 30 days post last dose up to 1.5 years
|
62.5%
5/8 • Start of treatment to 30 days post last dose up to 1.5 years
|
100.0%
5/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
60.0%
3/5 • Start of treatment to 30 days post last dose up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose up to 1.5 years
|
100.0%
2/2 • Start of treatment to 30 days post last dose up to 1.5 years
|
Additional Information
Repare Therapeutics Medical Monitor
Repare Therapeutics
Phone: 857-340-5402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place