Trial Outcomes & Findings for An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies (NCT NCT02431260)
NCT ID: NCT02431260
Last Updated: 2019-06-14
Results Overview
TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
69 participants
Primary outcome timeframe
up to 30 days
Results posted on
2019-06-14
Participant Flow
Participant milestones
| Measure |
Part 1 / Treatment Group A: 15 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 15 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 30 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.
Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
6
|
5
|
3
|
4
|
4
|
3
|
8
|
8
|
4
|
4
|
10
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
6
|
5
|
3
|
4
|
4
|
3
|
8
|
8
|
4
|
4
|
10
|
1
|
Reasons for withdrawal
| Measure |
Part 1 / Treatment Group A: 15 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 15 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 30 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.
Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Subject Decision
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
4
|
4
|
3
|
4
|
2
|
2
|
3
|
1
|
6
|
6
|
3
|
2
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Study Terminated by the Sponsor
|
0
|
0
|
2
|
1
|
1
|
0
|
1
|
2
|
1
|
1
|
1
|
0
|
4
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other Unspecified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
Baseline characteristics by cohort
| Measure |
Part 1 / Treatment Group A: 15 MG QD INCB054329
n=4 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG QD INCB054329
n=5 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 15 MG BID INCB054329
n=6 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 30 MG QD INCB054329
n=5 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID INCB054329
n=3 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
n=4 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.
Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
n=4 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
n=3 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
n=8 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
n=8 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
n=4 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
n=4 Participants
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=10 Participants
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
n=1 Participants
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 4.03 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 13.39 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 8.50 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 7.86 • n=4 Participants
|
68.7 years
STANDARD_DEVIATION 5.77 • n=21 Participants
|
49.3 years
STANDARD_DEVIATION 21.73 • n=8 Participants
|
61.5 years
STANDARD_DEVIATION 12.40 • n=8 Participants
|
68.3 years
STANDARD_DEVIATION 16.20 • n=24 Participants
|
58.4 years
STANDARD_DEVIATION 17.55 • n=42 Participants
|
60.9 years
STANDARD_DEVIATION 14.84 • n=42 Participants
|
50.3 years
STANDARD_DEVIATION 16.58 • n=42 Participants
|
71.8 years
STANDARD_DEVIATION 8.77 • n=42 Participants
|
59.3 years
STANDARD_DEVIATION 14.20 • n=36 Participants
|
66.0 years
n=36 Participants
|
60.03 years
STANDARD_DEVIATION 13.59 • n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
36 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
33 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
64 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
00 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
10 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
65 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Height
|
167.3 cm
STANDARD_DEVIATION 8.02 • n=5 Participants
|
172.7 cm
STANDARD_DEVIATION 11.47 • n=7 Participants
|
169.1 cm
STANDARD_DEVIATION 9.80 • n=5 Participants
|
164.6 cm
STANDARD_DEVIATION 10.48 • n=4 Participants
|
172.0 cm
STANDARD_DEVIATION 12.12 • n=21 Participants
|
164.8 cm
STANDARD_DEVIATION 16.52 • n=8 Participants
|
170.8 cm
STANDARD_DEVIATION 16.64 • n=8 Participants
|
174.2 cm
STANDARD_DEVIATION 14.65 • n=24 Participants
|
173.6 cm
STANDARD_DEVIATION 7.05 • n=42 Participants
|
170.5 cm
STANDARD_DEVIATION 12.60 • n=42 Participants
|
179.8 cm
STANDARD_DEVIATION 7.41 • n=42 Participants
|
167.0 cm
STANDARD_DEVIATION 13.29 • n=42 Participants
|
160.8 cm
STANDARD_DEVIATION 10.40 • n=36 Participants
|
159.0 cm
n=36 Participants
|
168 cm
STANDARD_DEVIATION 11.47 • n=24 Participants
|
|
Weight
|
70.0 kg
STANDARD_DEVIATION 9.19 • n=5 Participants
|
66.2 kg
STANDARD_DEVIATION 11.14 • n=7 Participants
|
71.7 kg
STANDARD_DEVIATION 18.32 • n=5 Participants
|
79.7 kg
STANDARD_DEVIATION 18.30 • n=4 Participants
|
77.6 kg
STANDARD_DEVIATION 18.55 • n=21 Participants
|
70.2 kg
STANDARD_DEVIATION 19.12 • n=8 Participants
|
72.3 kg
STANDARD_DEVIATION 24.39 • n=8 Participants
|
82.3 kg
STANDARD_DEVIATION 24.18 • n=24 Participants
|
87.3 kg
STANDARD_DEVIATION 18.24 • n=42 Participants
|
77.6 kg
STANDARD_DEVIATION 23.65 • n=42 Participants
|
88.4 kg
STANDARD_DEVIATION 36.32 • n=42 Participants
|
84.8 kg
STANDARD_DEVIATION 5.85 • n=42 Participants
|
66.3 kg
STANDARD_DEVIATION 19.90 • n=36 Participants
|
58.0 kg
n=36 Participants
|
75.69 kg
STANDARD_DEVIATION 19.82 • n=24 Participants
|
|
Body mass index (BMI)
|
25.2 kg/m^2
STANDARD_DEVIATION 4.34 • n=5 Participants
|
22.3 kg/m^2
STANDARD_DEVIATION 3.68 • n=7 Participants
|
24.8 kg/m^2
STANDARD_DEVIATION 5.00 • n=5 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 6.83 • n=4 Participants
|
26.1 kg/m^2
STANDARD_DEVIATION 4.62 • n=21 Participants
|
25.5 kg/m^2
STANDARD_DEVIATION 3.51 • n=8 Participants
|
24.3 kg/m^2
STANDARD_DEVIATION 5.10 • n=8 Participants
|
26.6 kg/m^2
STANDARD_DEVIATION 3.12 • n=24 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 4.85 • n=42 Participants
|
26.7 kg/m^2
STANDARD_DEVIATION 7.73 • n=42 Participants
|
27.2 kg/m^2
STANDARD_DEVIATION 10.69 • n=42 Participants
|
30.6 kg/m^2
STANDARD_DEVIATION 3.27 • n=42 Participants
|
25.5 kg/m^2
STANDARD_DEVIATION 6.46 • n=36 Participants
|
22.9 kg/m^2
n=36 Participants
|
26.36 kg/m^2
STANDARD_DEVIATION 5.75 • n=24 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
ECOG - 0
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
22 Participants
n=24 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
ECOG - 1
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
47 Participants
n=24 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
ECOG - >=2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: up to 30 daysPopulation: The safety population included all enrolled participants who received at least 1 dose of INCB054329.
TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Outcome measures
| Measure |
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=10 Participants
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
n=1 Participants
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=4 Participants
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
n=5 Participants
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
INCB054329 Monotherapy - 22.5 mg QD
n=6 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 30 mg QD
n=5 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 20 mg BID
n=3 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 22.5 mg BID
n=4 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 25 mg BID
n=4 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - Overall Dosing Regimen
n=3 Participants
INCB054329 Monotherapy
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
n=8 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
n=8 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
n=4 Participants
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
n=4 Participants
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
|
10 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
8 Participants
|
8 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Summary of steady-state PK parameters by dosing regimen at Day 15Population: All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.
Cmax is defined as the maximum observed serum concentration measured at steady state (Day 15). Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
Outcome measures
| Measure |
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=4 Participants
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
n=5 Participants
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
INCB054329 Monotherapy - 22.5 mg QD
n=4 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 30 mg QD
n=4 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 20 mg BID
n=14 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 22.5 mg BID
n=12 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 25 mg BID
n=8 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - Overall Dosing Regimen
n=51 Participants
INCB054329 Monotherapy
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) Analysis of INCB054329
|
—
|
—
|
278 nM
Standard Deviation 82.6
|
267 nM
Standard Deviation 201
|
479 nM
Standard Deviation 154
|
389 nM
Standard Deviation 393
|
652 nM
Standard Deviation 348
|
720 nM
Standard Deviation 472
|
449 nM
Standard Deviation 335
|
NA nM
Standard Deviation NA
Dose dependent parameter and overall summary not provided.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Summary of steady-state PK parameters by dosing regimen at Day 15Population: All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.
Tmax is the time to maximum (peak) drug serum concentration. Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
Outcome measures
| Measure |
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=4 Participants
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
n=5 Participants
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
INCB054329 Monotherapy - 22.5 mg QD
n=4 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 30 mg QD
n=4 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 20 mg BID
n=14 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 22.5 mg BID
n=12 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 25 mg BID
n=8 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - Overall Dosing Regimen
n=51 Participants
INCB054329 Monotherapy
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) Analysis of INCB054329
|
—
|
—
|
1.0 hour
Interval 0.52 to 1.0
|
0.93 hour
Interval 0.5 to 1.1
|
0.53 hour
Interval 0.5 to 1.0
|
1.0 hour
Interval 0.52 to 1.0
|
1.0 hour
Interval 0.48 to 2.0
|
1.0 hour
Interval 0.5 to 4.1
|
0.77 hour
Interval 0.5 to 2.2
|
1.0 hour
Interval 0.48 to 4.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Summary of steady-state PK parameters by dosing regimen at Day 15Population: All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.
Minimum observed plasma concentration measured at steady state (Day 15). Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
Outcome measures
| Measure |
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=4 Participants
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
n=5 Participants
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
INCB054329 Monotherapy - 22.5 mg QD
n=4 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 30 mg QD
n=4 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 20 mg BID
n=13 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 22.5 mg BID
n=12 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 25 mg BID
n=7 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - Overall Dosing Regimen
n=49 Participants
INCB054329 Monotherapy
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin) Analysis of INCB054329
|
—
|
—
|
0.538 nM
Standard Deviation 1.08
|
1.09 nM
Standard Deviation 2.45
|
0 nM
Standard Deviation 0
|
1.51 nM
Standard Deviation 3.02
|
54.2 nM
Standard Deviation 91.1
|
14.6 nM
Standard Deviation 45
|
0 nM
Standard Deviation 0
|
NA nM
Standard Deviation NA
Dose dependent parameter and overall summary not provided.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Summary of steady-state PK parameters by dosing regimen at Day 15Population: All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.
AUC0-t is the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). Study drug was administered with 240 mL of water.
Outcome measures
| Measure |
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=4 Participants
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
n=5 Participants
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
INCB054329 Monotherapy - 22.5 mg QD
n=4 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 30 mg QD
n=4 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 20 mg BID
n=14 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 22.5 mg BID
n=12 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 25 mg BID
n=8 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - Overall Dosing Regimen
n=51 Participants
INCB054329 Monotherapy
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-t Analysis of INCB054329
|
—
|
—
|
686 nM*h
Standard Deviation 178
|
611 nM*h
Standard Deviation 628
|
883 nM*h
Standard Deviation 409
|
1150 nM*h
Standard Deviation 1660
|
2130 nM*h
Standard Deviation 1690
|
1970 nM*h
Standard Deviation 1560
|
995 nM*h
Standard Deviation 843
|
NA nM*h
Standard Deviation NA
Dose dependent parameter and overall summary not provided.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Summary of steady-state PK parameters by dosing regimen at Day 15Population: All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.
Cl/F is the apparent oral dose clearance measured at steady state (Day 15). Study drug was administered with 240 mL of water.
Outcome measures
| Measure |
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=4 Participants
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
n=4 Participants
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
INCB054329 Monotherapy - 22.5 mg QD
n=4 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 30 mg QD
n=4 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 20 mg BID
n=14 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 22.5 mg BID
n=11 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 25 mg BID
n=7 Participants
INCB054329 Monotherapy
|
INCB054329 Monotherapy - Overall Dosing Regimen
n=48 Participants
INCB054329 Monotherapy
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cl/F Analysis of INCB054329
|
—
|
—
|
61.8 L/h
Standard Deviation 21.3
|
85.0 L/h
Standard Deviation 42.9
|
81.7 L/h
Standard Deviation 29.4
|
234 L/h
Standard Deviation 184
|
92.3 L/h
Standard Deviation 201
|
48.3 L/h
Standard Deviation 33.7
|
130 L/h
Standard Deviation 127
|
95.5 L/h
Standard Deviation 135
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15 in all cohortsPopulation: Individual data points from all subjects were subjected to a nonlinear least squares regression analysis with no weighting, resulting in a sigmoidal dose response curve defining the relationship. The numerical value given is the projected INCB0054329 concentration in nM that produced 50% inhibition of c-myc expression.
The half maximal inhibitory concentration (IC50) of INCB054329 was measured. The maximal inhibition of total c-Myc was correlated to the level of drug exposure and demonstrated a high degree of interparticipant variability, parallel to the PK data. The measure was performed as a value across all cohorts. The entire dose escalation data set was used to create the relationship curve. Analysis of individual cohorts contained too few subjects and was biased toward one region of the curve so that the relationship was poorly defined. Individual data points from all subjects were subjected to a nonlinear least squares regression analysis with no weighting, resulting in a sigmoidal dose response curve defining the relationship. The numerical value given is the projected INCB0054329 concentration in nM that produced 50% inhibition of c-myc expression.
Outcome measures
| Measure |
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=49 Participants
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
INCB054329 Monotherapy - 22.5 mg QD
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 30 mg QD
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 20 mg BID
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 22.5 mg BID
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 25 mg BID
INCB054329 Monotherapy
|
INCB054329 Monotherapy - Overall Dosing Regimen
INCB054329 Monotherapy
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD) Analysis - Total c-Myc % Inhibition Versus INCB054329
|
—
|
—
|
283.4 nM
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through end of study, up to 6 monthsPopulation: As a result of early termination of the study, only participants in Part 2 of the study were evaluated; Treatment Group C was not evaluated due to early termination from the study.
Defined as the percentage of subjects having complete response (CR) or partial response (PR). The best overall response was defined as the best response recorded before and including the first event of Progressive disease (PD).
Outcome measures
| Measure |
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=10 Participants
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
INCB054329 Monotherapy - 22.5 mg QD
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 30 mg QD
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 20 mg BID
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 22.5 mg BID
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 25 mg BID
INCB054329 Monotherapy
|
INCB054329 Monotherapy - Overall Dosing Regimen
INCB054329 Monotherapy
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
Complete response (CR)
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Objective Response Rate (ORR)
Partial response (PR)
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Objective Response Rate (ORR)
Stable disease (SD) >= 6 months
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Objective Response Rate (ORR)
Stable disease (SD) < 6 months
|
—
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Objective Response Rate (ORR)
Progressive disease (PD)
|
—
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Objective Response Rate (ORR)
Not evaluable (NE)
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through end of study, up to 6 monthsPopulation: As a result of early termination of the study, there are no participants that are responders and therefore DOR was not achieved.
Defined as the time from earliest date of disease response until earliest date of disease progression or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through end of study, up to 6 monthsPopulation: As a result of early termination of the study, only participants in Part 2 of the study were evaluated; Treatment Group C was not evaluated due to early termination from the study.
PFS is the time from start of study treatment to first documentation of progression, or to death due to any cause, whichever comes first
Outcome measures
| Measure |
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=10 Participants
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
INCB054329 Monotherapy - 22.5 mg QD
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 30 mg QD
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 20 mg BID
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 22.5 mg BID
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 25 mg BID
INCB054329 Monotherapy
|
INCB054329 Monotherapy - Overall Dosing Regimen
INCB054329 Monotherapy
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
—
|
—
|
2.04 months
Interval 0.63 to 4.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through end of study, up to 6 months for participants in Part 2Population: As a result of early termination of the study, only participants in Part 2 of the study were evaluated; Treatment Group C was not evaluated due to early termination from the study.
OS is defined as the time from the date of randomization to the date of the participant's death.
Outcome measures
| Measure |
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=10 Participants
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
INCB054329 Monotherapy - 22.5 mg QD
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 30 mg QD
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 20 mg BID
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 22.5 mg BID
INCB054329 Monotherapy
|
INCB054329 Monotherapy - 25 mg BID
INCB054329 Monotherapy
|
INCB054329 Monotherapy - Overall Dosing Regimen
INCB054329 Monotherapy
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
—
|
—
|
7.09 months
Interval 3.13 to
The upper CI limit of median PFS could not be estimated by the Brookmeyer and Crowley method because there were not enough events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 / Treatment Group A: 15 MG QD INCB054329
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Part 1 / Treatment Group A: 22.5 MG QD INCB054329
Serious events: 1 serious events
Other events: 5 other events
Deaths: 4 deaths
Part 1 / Treatment Group A: 15 MG BID INCB054329
Serious events: 1 serious events
Other events: 6 other events
Deaths: 3 deaths
Part 1 / Treatment Group A: 30 MG QD INCB054329
Serious events: 1 serious events
Other events: 5 other events
Deaths: 4 deaths
Part 1 / Treatment Group A: 22.5 MG BID INCB054329
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1 / Treatment Group A: 20 MG BID INCB054329
Serious events: 3 serious events
Other events: 8 other events
Deaths: 6 deaths
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Serious events: 3 serious events
Other events: 8 other events
Deaths: 6 deaths
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Serious events: 1 serious events
Other events: 2 other events
Deaths: 3 deaths
Part 1 / Treatment Group B: 20 MG BID INCB054329
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Part 2 / Treatment Group A: 20 MG BID INCB054329
Serious events: 3 serious events
Other events: 10 other events
Deaths: 6 deaths
Part 2 / Treatment Group C: 20 mg BID INCB054329
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part 1 / Treatment Group A: 15 MG QD INCB054329
n=4 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG QD INCB054329
n=5 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 15 MG BID INCB054329
n=6 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 30 MG QD INCB054329
n=5 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID INCB054329
n=3 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
n=4 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.
Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
n=4 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
n=3 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
n=8 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
n=8 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
n=4 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
n=4 participants at risk
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=10 participants at risk
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
n=1 participants at risk
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
100.0%
1/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
100.0%
1/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Multi-organ failure
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic vein thrombosis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
66.7%
2/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
66.7%
2/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
Other adverse events
| Measure |
Part 1 / Treatment Group A: 15 MG QD INCB054329
n=4 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG QD INCB054329
n=5 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 15 MG BID INCB054329
n=6 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 30 MG QD INCB054329
n=5 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID INCB054329
n=3 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
n=4 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.
Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
n=4 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
n=3 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 20 MG BID INCB054329
n=8 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
n=8 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
n=4 participants at risk
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 1 / Treatment Group B: 20 MG BID INCB054329
n=4 participants at risk
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
|
Part 2 / Treatment Group A: 20 MG BID INCB054329
n=10 participants at risk
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
|
Part 2 / Treatment Group C: 20 mg BID INCB054329
n=1 participants at risk
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Eye disorders
Eye discharge
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
40.0%
2/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
30.0%
3/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
37.5%
3/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Axillary pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Early satiety
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
2/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Feeling abnormal
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
2/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Psychiatric disorders
Apathy
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
2/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
37.5%
3/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
100.0%
3/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
75.0%
3/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
37.5%
3/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
66.7%
2/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
37.5%
3/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
40.0%
2/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
66.7%
2/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
37.5%
3/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
60.0%
3/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
66.7%
2/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
40.0%
2/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
60.0%
3/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
66.7%
2/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
62.5%
5/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
62.5%
5/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
40.0%
2/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
4/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
100.0%
1/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
60.0%
3/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
60.0%
3/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
66.7%
2/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
75.0%
3/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
66.7%
2/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
4/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
2/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
66.7%
2/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
66.7%
2/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
4/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
30.0%
3/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
37.5%
3/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
30.0%
3/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
60.0%
3/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
75.0%
3/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
37.5%
3/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
75.0%
3/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
30.0%
3/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
37.5%
3/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
30.0%
3/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
100.0%
1/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
2/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
37.5%
3/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
2/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
2/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
40.0%
2/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
2/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
40.0%
2/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
50.0%
2/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
12.5%
1/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
2/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
10.0%
1/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
16.7%
1/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
20.0%
1/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
33.3%
1/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/6 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/5 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/3 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/8 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
25.0%
1/4 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/10 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
0.00%
0/1 • From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER