Trial Outcomes & Findings for A Phase Ib/II Study of LEE011 in Combination With MEK162 in Patients With NRAS Mutant Melanoma (NCT NCT01781572)
NCT ID: NCT01781572
Last Updated: 2020-12-07
Results Overview
To estimate the maximum tolerate doses (MTDs) and/or identify the RP2D and schedule of LEE011 and MEK162 combination. A dose-limiting toxicity (DLT) was defined as an AE or clinically significant abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first cycle of treatment with ribociclib and binimetinib.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
102 participants
Primary outcome timeframe
first 28 days of treatment
Results posted on
2020-12-07
Participant Flow
Upon study entry, all patients were required to provide either an archival tumor biopsy with the corresponding pathology report or a newly obtained tumor biopsy. Both parts of the study were limited to patients aged 18 or older with metastatic or locally advanced NRAS-mutant melanoma.
Screening details: Screening assessments were performed within 14 days prior to the first dose of ribociclib and binimetinib except for the pretreatment tumor biopsy, which was performed within 28 days before dosing. A total of 23 patients were screened but not enrolled.
Participant milestones
| Measure |
Phase 1b 28-Day Schedule
A combined total of 61 patients were treated in the 28-day (n=29) and 21-day (n=32) treatment cycles, and all patients discontinued treatment. The starting dose in the 28-day schedule was binimetinib 45 mg BID + ribociclib 200 mg QD.
28-Day Schedule: ribociclib was taken QD for 21 consecutive days followed by a 7-day planned break.
Binimetinib was taken BID on a continuous dosing schedule.
|
Phase 1b 21-Day Schedule
A combined total of 61 patients were treated in the 28-day (n=29) and 21-day (n=32) treatment cycles, and all patients discontinued treatment. The starting dose in the 21-day schedule was binimetinib 30 mg BID + ribociclib 200 mg QD.
21-Day Schedule: ribociclib QD and binimetinib BID were taken QD for 14 consecutive days followed by a 7-day planned break.
|
Phase 2 (Dose-expansion Phase)
The dose-expansion phase was initiated with a newly recruited group of patients.
A total of 41 patients were treated, and all patients (100%) discontinued treatment. Based on the recommendations of the dose-escalation meetings between the Sponsor and the Investigators, the RP2D and schedule for the combination of binimetinib and ribociclib to be used for the dose-expansion phase of the study was binimetinib 45 mg BID + ribociclib 200 mg QD on the 28-day schedule.
|
|---|---|---|---|
|
MEK162 45mg BID+LEE011 200mg
STARTED
|
16
|
6
|
41
|
|
MEK162 45mg BID+LEE011 200mg
COMPLETED
|
0
|
0
|
0
|
|
MEK162 45mg BID+LEE011 200mg
NOT COMPLETED
|
16
|
6
|
41
|
|
MEK162 45mg BID+LEE011 250mg
STARTED
|
3
|
0
|
0
|
|
MEK162 45mg BID+LEE011 250mg
COMPLETED
|
0
|
0
|
0
|
|
MEK162 45mg BID+LEE011 250mg
NOT COMPLETED
|
3
|
0
|
0
|
|
MEK162 30mg BID+LEE011 300mg
STARTED
|
4
|
2
|
0
|
|
MEK162 30mg BID+LEE011 300mg
COMPLETED
|
0
|
0
|
0
|
|
MEK162 30mg BID+LEE011 300mg
NOT COMPLETED
|
4
|
2
|
0
|
|
MEK162 45mg BID+LEE011 300mg
STARTED
|
6
|
4
|
0
|
|
MEK162 45mg BID+LEE011 300mg
COMPLETED
|
0
|
0
|
0
|
|
MEK162 45mg BID+LEE011 300mg
NOT COMPLETED
|
6
|
4
|
0
|
|
MEK162 30mg LEE011 200mg
STARTED
|
0
|
5
|
0
|
|
MEK162 30mg LEE011 200mg
COMPLETED
|
0
|
0
|
0
|
|
MEK162 30mg LEE011 200mg
NOT COMPLETED
|
0
|
5
|
0
|
|
MEK162 45mg LEE011 450mg
STARTED
|
0
|
9
|
0
|
|
MEK162 45mg LEE011 450mg
COMPLETED
|
0
|
0
|
0
|
|
MEK162 45mg LEE011 450mg
NOT COMPLETED
|
0
|
9
|
0
|
|
MEK162 45mg LEE011 600mg
STARTED
|
0
|
6
|
0
|
|
MEK162 45mg LEE011 600mg
COMPLETED
|
0
|
0
|
0
|
|
MEK162 45mg LEE011 600mg
NOT COMPLETED
|
0
|
6
|
0
|
Reasons for withdrawal
| Measure |
Phase 1b 28-Day Schedule
A combined total of 61 patients were treated in the 28-day (n=29) and 21-day (n=32) treatment cycles, and all patients discontinued treatment. The starting dose in the 28-day schedule was binimetinib 45 mg BID + ribociclib 200 mg QD.
28-Day Schedule: ribociclib was taken QD for 21 consecutive days followed by a 7-day planned break.
Binimetinib was taken BID on a continuous dosing schedule.
|
Phase 1b 21-Day Schedule
A combined total of 61 patients were treated in the 28-day (n=29) and 21-day (n=32) treatment cycles, and all patients discontinued treatment. The starting dose in the 21-day schedule was binimetinib 30 mg BID + ribociclib 200 mg QD.
21-Day Schedule: ribociclib QD and binimetinib BID were taken QD for 14 consecutive days followed by a 7-day planned break.
|
Phase 2 (Dose-expansion Phase)
The dose-expansion phase was initiated with a newly recruited group of patients.
A total of 41 patients were treated, and all patients (100%) discontinued treatment. Based on the recommendations of the dose-escalation meetings between the Sponsor and the Investigators, the RP2D and schedule for the combination of binimetinib and ribociclib to be used for the dose-expansion phase of the study was binimetinib 45 mg BID + ribociclib 200 mg QD on the 28-day schedule.
|
|---|---|---|---|
|
MEK162 45mg BID+LEE011 200mg
Adverse Event
|
7
|
0
|
11
|
|
MEK162 45mg BID+LEE011 200mg
Progressive disease
|
8
|
6
|
23
|
|
MEK162 45mg BID+LEE011 200mg
Withdrawal by Subject
|
1
|
0
|
2
|
|
MEK162 45mg BID+LEE011 200mg
Physician Decision
|
0
|
0
|
4
|
|
MEK162 45mg BID+LEE011 200mg
Death
|
0
|
0
|
1
|
|
MEK162 45mg BID+LEE011 250mg
Progressive Disease
|
2
|
0
|
0
|
|
MEK162 45mg BID+LEE011 250mg
Withdrawal by Subject
|
1
|
0
|
0
|
|
MEK162 30mg BID+LEE011 300mg
Adverse Event
|
1
|
0
|
0
|
|
MEK162 30mg BID+LEE011 300mg
Progressive Disease
|
3
|
2
|
0
|
|
MEK162 45mg BID+LEE011 300mg
Adverse Event
|
1
|
1
|
0
|
|
MEK162 45mg BID+LEE011 300mg
Progressive Disease
|
4
|
3
|
0
|
|
MEK162 45mg BID+LEE011 300mg
Death
|
1
|
0
|
0
|
|
MEK162 30mg LEE011 200mg
Progressive Disease
|
0
|
5
|
0
|
|
MEK162 45mg LEE011 450mg
Adverse Event
|
0
|
1
|
0
|
|
MEK162 45mg LEE011 450mg
Physician Decision
|
0
|
2
|
0
|
|
MEK162 45mg LEE011 450mg
Progressive Disease
|
0
|
6
|
0
|
|
MEK162 45mg LEE011 600mg
Adverse Event
|
0
|
1
|
0
|
|
MEK162 45mg LEE011 600mg
Progressive Disease
|
0
|
5
|
0
|
Baseline Characteristics
A Phase Ib/II Study of LEE011 in Combination With MEK162 in Patients With NRAS Mutant Melanoma
Baseline characteristics by cohort
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=16 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=3 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=4 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=6 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=5 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=6 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=9 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=6 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
n=41 Participants
MEK162 45mg+LEE011 200mg
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
54 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
48 Participants
n=42 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 14.51 • n=5 Participants
|
57 years
STANDARD_DEVIATION 9.02 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 21.30 • n=5 Participants
|
56 years
STANDARD_DEVIATION 15.04 • n=4 Participants
|
63.0 years
STANDARD_DEVIATION 7.50 • n=21 Participants
|
62.5 years
STANDARD_DEVIATION 12.687 • n=8 Participants
|
55.0 years
STANDARD_DEVIATION 18.38 • n=8 Participants
|
63.5 years
STANDARD_DEVIATION 19.48 • n=24 Participants
|
67.0 years
STANDARD_DEVIATION 8.59 • n=42 Participants
|
58.5 years
STANDARD_DEVIATION 5.56 • n=42 Participants
|
65 years
STANDARD_DEVIATION 12.35 • n=42 Participants
|
61 years
STANDARD_DEVIATION 12.72 • n=42 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
41 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
61 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
16 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
100 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
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
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Weight
|
82.57 kilograms
STANDARD_DEVIATION 15.014 • n=5 Participants
|
91.47 kilograms
STANDARD_DEVIATION 20.093 • n=7 Participants
|
71.30 kilograms
STANDARD_DEVIATION 12.631 • n=5 Participants
|
97.48 kilograms
STANDARD_DEVIATION 35.464 • n=4 Participants
|
73.66 kilograms
STANDARD_DEVIATION 8.104 • n=21 Participants
|
85.20 kilograms
STANDARD_DEVIATION 20.733 • n=8 Participants
|
80.80 kilograms
STANDARD_DEVIATION 15.274 • n=8 Participants
|
97.20 kilograms
STANDARD_DEVIATION 24.554 • n=24 Participants
|
92.41 kilograms
STANDARD_DEVIATION 20.709 • n=42 Participants
|
62.95 kilograms
STANDARD_DEVIATION 6.111 • n=42 Participants
|
79.63 kilograms
STANDARD_DEVIATION 17.334 • n=42 Participants
|
83.69 kilograms
STANDARD_DEVIATION 20.621 • n=42 Participants
|
|
Body mass index
|
28.57 (kg)/m^2
STANDARD_DEVIATION 5.136 • n=5 Participants
|
26.84 (kg)/m^2
STANDARD_DEVIATION 5.332 • n=7 Participants
|
25.95 (kg)/m^2
STANDARD_DEVIATION 3.347 • n=5 Participants
|
30.38 (kg)/m^2
STANDARD_DEVIATION 9.733 • n=4 Participants
|
23.85 (kg)/m^2
STANDARD_DEVIATION 2.451 • n=21 Participants
|
27.80 (kg)/m^2
STANDARD_DEVIATION 6.185 • n=8 Participants
|
27.92 (kg)/m^2
STANDARD_DEVIATION 7.526 • n=8 Participants
|
31.71 (kg)/m^2
STANDARD_DEVIATION 5.305 • n=24 Participants
|
28.08 (kg)/m^2
STANDARD_DEVIATION 6.594 • n=42 Participants
|
23.50 (kg)/m^2
STANDARD_DEVIATION 3.293 • n=42 Participants
|
26.69 (kg)/m^2
STANDARD_DEVIATION 5.014 • n=42 Participants
|
27.34 (kg)/m^2
STANDARD_DEVIATION 5.841 • n=42 Participants
|
|
ECOG performance status
0-Without restriction
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
65 Participants
n=42 Participants
|
|
ECOG performance status
1-Restricted in physically strenuous activity
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
35 Participants
n=42 Participants
|
|
ECOG performance status
2-Ambulatory and capable of all selfcare
|
1 Participants
n=5 Participants
|
1 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
|
2 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: first 28 days of treatmentPopulation: Analysis is comprised of the dose-determining set, which is all patients from the safety set who either met the minimum exposure criterion below and had sufficient safety evaluations during Cycle 1 or discontinued earlier due to DLT during Cycle 1.
To estimate the maximum tolerate doses (MTDs) and/or identify the RP2D and schedule of LEE011 and MEK162 combination. A dose-limiting toxicity (DLT) was defined as an AE or clinically significant abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first cycle of treatment with ribociclib and binimetinib.
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=16 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=3 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=4 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=6 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=5 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=6 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=9 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=6 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Dose Limiting Toxicities (Phase Ib)
|
2 occurrence
|
0 occurrence
|
1 occurrence
|
3 occurrence
|
0 occurrence
|
1 occurrence
|
0 occurrence
|
1 occurrence
|
2 occurrence
|
0 occurrence
|
—
|
PRIMARY outcome
Timeframe: Approximately 12 months after the FPFVPopulation: Analysis population consist of the Full Analysis Set, which included all patients who received at least one dose of binimetinib or ribociclib and was used for the analysis of all endpoints unless noted otherwise.
ORR is the proportion of patients with best overall response of complete response (CR) or partial response (PR) by month 2 assessed according to RECIST 1.1 criteria. ORR is done to describe the anti-tumor activity of LEE011 and MEK162 combination. The primary analysis of the ORR was based on the Investigator's assessment of overall lesion responses per RECIST 1.1.
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=41 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) (Phase II)
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Analysis population consist of the pharmacokinetic analysis set (PAS) which consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=15 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=3 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=4 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=6 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=4 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=5 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=9 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=5 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (AUCtau) of LEE011 (Phase Ib)
|
2120 h*ng/ml
Geometric Coefficient of Variation 66.2
|
3020 h*ng/ml
Geometric Coefficient of Variation 99.4
|
5280 h*ng/ml
Geometric Coefficient of Variation 27.8
|
3860 h*ng/ml
Geometric Coefficient of Variation 42.3
|
2340 h*ng/ml
Geometric Coefficient of Variation 113
|
2230 h*ng/ml
Geometric Coefficient of Variation 74.5
|
5020 h*ng/ml
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
2960 h*ng/ml
Geometric Coefficient of Variation 46.4
|
5550 h*ng/ml
Geometric Coefficient of Variation 50.3
|
9840 h*ng/ml
Geometric Coefficient of Variation 65.7
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: The analysis group is comprised of the pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=6 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=1 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=1 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=2 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=3 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=1 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=2 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=1 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (AUCtau) of MEK162 (Phase Ib)
|
1310 h*ng/ml
Geometric Coefficient of Variation 36.8
|
1070 h*ng/ml
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
1640 h*ng/ml
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
1240 h*ng/ml
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
1610 h*ng/ml
Geometric Coefficient of Variation 76
|
1820 h*ng/ml
Geometric Coefficient of Variation 82.1
|
747 h*ng/ml
Geometric Coefficient of Variation 31.8
|
2740 h*ng/ml
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
2110 h*ng/ml
Geometric Coefficient of Variation 44.2
|
4060 h*ng/ml
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
—
|
SECONDARY outcome
Timeframe: For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14Population: The analysis group is comprised of the pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=13 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=1 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=2 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=4 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=5 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=2 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=5 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=5 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (AUCtau,ss) of LEE011 (Phase Ib)
|
3080 h*ng/mL
Geometric Coefficient of Variation 63.2
|
15000 h*ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
8650 h*ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
7050 h*ng/mL
Geometric Coefficient of Variation 41.3
|
4700 h*ng/mL
Geometric Coefficient of Variation 28.9
|
4370 h*ng/mL
Geometric Coefficient of Variation 60.3
|
7480 h*ng/mL
Geometric Coefficient of Variation 2.89
|
9570 h*ng/mL
Geometric Coefficient of Variation 50.5
|
11100 h*ng/mL
Geometric Coefficient of Variation 29.1
|
30700 h*ng/mL
Geometric Coefficient of Variation 46.4
|
—
|
SECONDARY outcome
Timeframe: For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14Population: The analysis group is comprised of the pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=11 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=1 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=4 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=4 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=3 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=4 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=5 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (AUCtau,ss) of MEK162 (Phase Ib)
|
2250 h*ng/mL
Geometric Coefficient of Variation 37.7
|
2450 h*ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
—
|
1540 h*ng/mL
Geometric Coefficient of Variation 30.0
|
2180 h*ng/mL
Geometric Coefficient of Variation 12.1
|
2980 h*ng/mL
Geometric Coefficient of Variation 58.9
|
1990 h*ng/mL
Geometric Coefficient of Variation 22.2
|
3680 h*ng/mL
Geometric Coefficient of Variation 40.9
|
2840 h*ng/mL
Geometric Coefficient of Variation 57.5
|
3340 h*ng/mL
Geometric Coefficient of Variation 86.5
|
—
|
SECONDARY outcome
Timeframe: For the 28-day schedule the steady-state parameter time frame was predose on Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was predose on Cycle 1 Day 14Population: Analysis population consist of the pharmacokinetic analysis set (PAS), which consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=14 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=2 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=4 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=5 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=2 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=5 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=6 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (Cmin,ss) of LEE011 (Phase Ib)
|
88.1 ng/mL
Geometric Coefficient of Variation 56.3
|
256 ng/mL
Geometric Coefficient of Variation 79.8
|
220 ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
113 ng/mL
Geometric Coefficient of Variation 56.4
|
117 ng/mL
Geometric Coefficient of Variation 39.8
|
97.6 ng/mL
Geometric Coefficient of Variation 77.8
|
140 ng/mL
Geometric Coefficient of Variation 25.6
|
216 ng/mL
Geometric Coefficient of Variation 7.88
|
264 ng/mL
Geometric Coefficient of Variation 44.9
|
570 ng/mL
Geometric Coefficient of Variation 91.3
|
—
|
SECONDARY outcome
Timeframe: For the 28-day schedule the steady-state parameter time frame was predose on Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was predose on Cycle 1 Day 14Population: Analysis population consist of the pharmacokinetic analysis set (PAS), which consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=11 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=2 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=3 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=4 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=4 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=3 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=4 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=6 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (Cmin,ss) of MEK162 (Phase Ib)
|
73.2 ng/mL
Geometric Coefficient of Variation 75.4
|
188 ng/mL
Geometric Coefficient of Variation 73.9
|
84.2 ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
43.9 ng/mL
Geometric Coefficient of Variation 60.7
|
103 ng/mL
Geometric Coefficient of Variation 31.4
|
90.4 ng/mL
Geometric Coefficient of Variation 20.0
|
123 ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
178 ng/mL
Geometric Coefficient of Variation 38.1
|
63.9 ng/mL
Geometric Coefficient of Variation 94.3
|
179 ng/mL
Geometric Coefficient of Variation 98.3
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: The analysis group is comprised of the pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=15 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=3 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=4 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=6 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=4 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=5 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=9 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=5 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (Cmax) of LEE011 (Phase Ib)
|
217 ng/mL
Geometric Coefficient of Variation 90.5
|
271 ng/mL
Geometric Coefficient of Variation 87.4
|
555 ng/mL
Geometric Coefficient of Variation 44.4
|
374 ng/mL
Geometric Coefficient of Variation 47.9
|
236 ng/mL
Geometric Coefficient of Variation 143
|
229 ng/mL
Geometric Coefficient of Variation 86.0
|
368 ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
307 ng/mL
Geometric Coefficient of Variation 33.0
|
506 ng/mL
Geometric Coefficient of Variation 65.6
|
1030 ng/mL
Geometric Coefficient of Variation 54.1
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: The analysis group is comprised of the pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=15 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=3 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=3 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=6 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=5 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=6 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=9 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=5 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (Cmax) of MEK162 (Phase Ib)
|
315 ng/mL
Geometric Coefficient of Variation 55.7
|
296 ng/mL
Geometric Coefficient of Variation 48.4
|
247 ng/mL
Geometric Coefficient of Variation 59.7
|
231 ng/mL
Geometric Coefficient of Variation 47.3
|
234 ng/mL
Geometric Coefficient of Variation 73.9
|
453 ng/mL
Geometric Coefficient of Variation 67.1
|
163 ng/mL
Geometric Coefficient of Variation 47.8
|
396 ng/mL
Geometric Coefficient of Variation 52.7
|
385 ng/mL
Geometric Coefficient of Variation 50.3
|
402 ng/mL
Geometric Coefficient of Variation 69.8
|
—
|
SECONDARY outcome
Timeframe: For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14Population: The analysis group is comprised of the pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=14 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=2 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=5 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=5 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=2 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=5 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=6 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (Cmax,ss) of LEE011 (Phase Ib)
|
220 ng/mL
Geometric Coefficient of Variation 76.5
|
343 ng/mL
Geometric Coefficient of Variation 150
|
220 ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
530 ng/mL
Geometric Coefficient of Variation 30.6
|
373 ng/mL
Geometric Coefficient of Variation 62.4
|
341 ng/mL
Geometric Coefficient of Variation 69.0
|
543 ng/mL
Geometric Coefficient of Variation 11.9
|
747 ng/mL
Geometric Coefficient of Variation 33.0
|
727 ng/mL
Geometric Coefficient of Variation 34.7
|
1910 ng/mL
Geometric Coefficient of Variation 38.5
|
—
|
SECONDARY outcome
Timeframe: For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14Population: The analysis group is comprised of the pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=11 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=2 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=5 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=4 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=3 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=4 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=6 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (Cmax,ss) of MEK162 (Phase Ib)
|
441 ng/mL
Geometric Coefficient of Variation 52.6
|
309 ng/mL
Geometric Coefficient of Variation 1.60
|
—
|
284 ng/mL
Geometric Coefficient of Variation 14.5
|
376 ng/mL
Geometric Coefficient of Variation 18.0
|
444 ng/mL
Geometric Coefficient of Variation 36.6
|
367 ng/mL
Geometric Coefficient of Variation 31.5
|
590 ng/mL
Geometric Coefficient of Variation 12.3
|
452 ng/mL
Geometric Coefficient of Variation 59.2
|
471 ng/mL
Geometric Coefficient of Variation 75.6
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Analysis population consist of the pharmacokinetic analysis set (PAS), which consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=15 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=3 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=4 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=6 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=4 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=5 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=9 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=5 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (Tmax) of LEE011 (Phase Ib)
|
2.12 h
Interval 1.0 to 24.92
|
3.75 h
Interval 2.12 to 4.1
|
2.98 h
Interval 0.67 to 4.08
|
1.50 h
Interval 0.52 to 4.0
|
2.98 h
Interval 1.98 to 7.95
|
1.12 h
Interval 0.87 to 3.83
|
4.22 h
Interval 4.22 to 4.22
|
1.50 h
Interval 1.0 to 8.0
|
2.13 h
Interval 1.0 to 4.03
|
2.03 h
Interval 1.62 to 2.13
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Analysis population consist of the pharmacokinetic analysis set (PAS), which consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=15 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=3 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=3 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=6 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=5 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=6 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=9 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=5 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (Tmax) of MEK162 (Phase Ib)
|
1.08 h
Interval 0.85 to 8.0
|
2.05 h
Interval 0.5 to 2.12
|
1.02 h
Interval 1.0 to 1.97
|
2.00 h
Interval 0.52 to 4.0
|
1.98 h
Interval 0.43 to 7.95
|
1.11 h
Interval 0.87 to 2.05
|
0.76 h
Interval 0.52 to 1.0
|
2.00 h
Interval 1.0 to 4.15
|
2.17 h
Interval 1.0 to 8.08
|
1.17 h
Interval 0.47 to 4.02
|
—
|
SECONDARY outcome
Timeframe: For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14Population: Analysis population consist of the pharmacokinetic analysis set (PAS), which consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=14 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=2 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=5 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=5 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=2 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=5 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=6 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (Tmax,ss) of LEE011 (Phase Ib)
|
2.25 h
Interval 0.0 to 7.5
|
5.90 h
Interval 4.0 to 7.8
|
23.93 h
Interval 23.93 to 23.93
|
2.99 h
Interval 2.0 to 4.0
|
4.00 h
Interval 1.03 to 7.87
|
1.87 h
Interval 0.5 to 4.08
|
2.03 h
Interval 1.93 to 2.12
|
4.05 h
Interval 2.08 to 6.02
|
3.92 h
Interval 2.08 to 4.13
|
1.93 h
Interval 1.02 to 4.0
|
—
|
SECONDARY outcome
Timeframe: For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14Population: Analysis population consist of the pharmacokinetic analysis set (PAS), which consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=11 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=2 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=5 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=4 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=3 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=4 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=6 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (Tmax,ss) of MEK162 (Phase Ib)
|
1.00 h
Interval 0.75 to 4.03
|
3.03 h
Interval 1.97 to 4.1
|
—
|
2.31 h
Interval 1.0 to 4.0
|
1.00 h
Interval 0.53 to 4.13
|
1.96 h
Interval 1.0 to 3.95
|
1.49 h
Interval 1.05 to 1.93
|
2.02 h
Interval 1.08 to 6.02
|
1.92 h
Interval 0.98 to 2.08
|
1.49 h
Interval 0.0 to 3.63
|
—
|
SECONDARY outcome
Timeframe: For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14Population: Analysis population consist of the pharmacokinetic analysis set (PAS), which consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=13 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=1 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=4 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=5 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=2 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=5 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=5 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (Accumulation Ratio, Racc_AUC) of LEE011 (Phase Ib)
|
1.51 (hr*ng/mL) / (hr*ng/mL)
Geometric Coefficient of Variation 53.9
|
2.52 (hr*ng/mL) / (hr*ng/mL)
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
2.25 (hr*ng/mL) / (hr*ng/mL)
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
2.29 (hr*ng/mL) / (hr*ng/mL)
Geometric Coefficient of Variation 38.4
|
2.89 (hr*ng/mL) / (hr*ng/mL)
Geometric Coefficient of Variation 32.8
|
2.28 (hr*ng/mL) / (hr*ng/mL)
Geometric Coefficient of Variation 54.6
|
3.29 (hr*ng/mL) / (hr*ng/mL)
Geometric Coefficient of Variation 165
|
3.50 (hr*ng/mL) / (hr*ng/mL)
Geometric Coefficient of Variation 8.68
|
1.97 (hr*ng/mL) / (hr*ng/mL)
Geometric Coefficient of Variation 45.4
|
3.95 (hr*ng/mL) / (hr*ng/mL)
Geometric Coefficient of Variation 58.6
|
—
|
SECONDARY outcome
Timeframe: For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14Population: Analysis population consist of the pharmacokinetic analysis set (PAS), which consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=13 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=1 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=4 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=5 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=2 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=5 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=5 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (Accumulation Ratio, Racc_AUC) of MEK162 (Phase Ib)
|
2.53 (hr*ng/mL) / (hr*ng/mL
Geometric Coefficient of Variation 45.8
|
7.59 (hr*ng/mL) / (hr*ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
1.74 (hr*ng/mL) / (hr*ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
3.39 (hr*ng/mL) / (hr*ng/mL
Geometric Coefficient of Variation 15.2
|
4.47 (hr*ng/mL) / (hr*ng/mL
Geometric Coefficient of Variation 21.5
|
2.26 (hr*ng/mL) / (hr*ng/mL
Geometric Coefficient of Variation 27.3
|
3.14 (hr*ng/mL) / (hr*ng/mL
Geometric Coefficient of Variation 161
|
3.48 (hr*ng/mL) / (hr*ng/mL
Geometric Coefficient of Variation 53.0
|
2.09 (hr*ng/mL) / (hr*ng/mL
Geometric Coefficient of Variation 53.5
|
3.06 (hr*ng/mL) / (hr*ng/mL
Geometric Coefficient of Variation 26.0
|
—
|
SECONDARY outcome
Timeframe: For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14Population: Analysis population consist of the pharmacokinetic analysis set (PAS), which consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=11 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=1 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=4 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=5 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=2 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=4 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=5 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (T1/2,ss) of LEE011 (Phase Ib)
|
16.7 h
Geometric Coefficient of Variation 83.6
|
32.9 h
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
28.2 h
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
28.0 h
Geometric Coefficient of Variation 54.7
|
38.5 h
Geometric Coefficient of Variation 44.4
|
26.9 h
Geometric Coefficient of Variation 82.0
|
275 h
Geometric Coefficient of Variation 64.5
|
49.5 h
Geometric Coefficient of Variation 10.3
|
30.3 h
Geometric Coefficient of Variation 17.6
|
55.3 h
Geometric Coefficient of Variation 73.1
|
—
|
SECONDARY outcome
Timeframe: For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14Population: Analysis population consist of the pharmacokinetic analysis set (PAS), which consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=11 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=2 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=4 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=4 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=3 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=4 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=5 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (T1/2,ss) of MEK162 (Phase Ib)
|
8.17 h
Geometric Coefficient of Variation 30.6
|
7.38 h
Geometric Coefficient of Variation 92.6
|
—
|
6.33 h
Geometric Coefficient of Variation 81.1
|
15.0 h
Geometric Coefficient of Variation 54.8
|
5.21 h
Geometric Coefficient of Variation 73.2
|
15.4 h
Geometric Coefficient of Variation 11.4
|
8.95 h
Geometric Coefficient of Variation 23.9
|
8.73 h
Geometric Coefficient of Variation 19.3
|
12.0 h
Geometric Coefficient of Variation 31.2
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Analysis population consist of the pharmacokinetic analysis set (PAS), which consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=8 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=1 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=5 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=2 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=3 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=3 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=4 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=5 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (CL/F) of LEE011 (Phase Ib)
|
72.7 L/h
Geometric Coefficient of Variation 75.4
|
41.2 L/h
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
39.2 L/h
Geometric Coefficient of Variation 26.7
|
67.6 L/h
Geometric Coefficient of Variation 35.9
|
34.3 L/h
Geometric Coefficient of Variation 81.7
|
57.2 L/h
Geometric Coefficient of Variation 52.7
|
—
|
93.9 L/h
Geometric Coefficient of Variation 36.1
|
78.4 L/h
Geometric Coefficient of Variation 16.0
|
48.7 L/h
Geometric Coefficient of Variation 68.8
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Analysis population consist of the pharmacokinetic analysis set (PAS), which consisted of all patients who had at least one blood sample providing evaluable PK data and received at least one dose of study drug.
To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib).
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=6 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=1 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=1 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=1 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=2 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=3 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=1 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=2 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=1 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration-time Profile (CL/F) of MEK162 (Phase Ib)
|
32.5 L/h
Geometric Coefficient of Variation 36.3
|
35.9 L/h
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
17.8 L/h
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
35.5 L/h
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
17.9 L/h
Geometric Coefficient of Variation 80.7
|
23.9 L/h
Geometric Coefficient of Variation 83.6
|
37.2 L/h
Geometric Coefficient of Variation 23.0
|
15.9 L/h
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
20.8 L/h
Geometric Coefficient of Variation 45.8
|
10.2 L/h
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate.
|
—
|
SECONDARY outcome
Timeframe: Approximately 12 months after FPFVPopulation: Analysis group consists of the safety set, which included all patients who received at least 1 dose of ribociclib or binimetinib and had at least 1 postbaseline safety assessment.
Safety and tolerability will be characterized through the incidence and severity of adverse drug reactions, serious adverse drug reactions, changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, dose reduction and dose intensity.
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=16 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=3 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=4 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
n=6 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
n=5 Participants
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
n=6 Participants
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
n=2 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
n=4 Participants
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
n=9 Participants
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
n=6 Participants
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
n=41 Participants
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Drug Reactions
|
16 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
9 Participants
|
6 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Approximately 12 months after the FPFVPopulation: Analysis population consist of the Full Analysis Set, which included all patients who received at least one dose of binimetinib or ribociclib and was used for the analysis of all endpoints unless noted otherwise.
To assess clinical safety as per RECIST 1.1. Evaluation will occur continuously throughout the trial until progression, or death due to underlying cancer. Please note: As clinicaltrials.gov only allows numerical data entry, the value of 999 indicates "not estimable" for confidence interval.
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=41 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR) - Phase 2
|
10.3 months
Interval 4.1 to 999.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 12 months after the FPFVPopulation: Analysis population consist of the Full Analysis Set, which included all patients who received at least one dose of binimetinib or ribociclib and was used for the analysis of all endpoints unless noted otherwise.
To assess clinical safety as per RECIST 1.1. Evaluation will occur continuously throughout the trial until progression, or death due to underlying cancer.
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=41 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP) - Phase 2
|
3.7 months
Interval 3.5 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 12 months after the FPFVPopulation: Analysis population consist of the Full Analysis Set, which included all patients who received at least one dose of binimetinib or ribociclib and was used for the analysis of all endpoints unless noted otherwise.
To assess clinical safety as per RECIST 1.1. Evaluation will occur continuously throughout the trial until progression, or death due to underlying cancer. In the Phase 1b part, patients were combined for purposes of PFS analyses based on schedule received, since too few patients received any individual dose level to allow for valid PFS estimates within the respective dose levels. This is how the data were analyses and presented for the clinical study report.
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=29 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
n=32 Participants
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
n=41 Participants
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) - Phase 1b and Phase 2
|
6.7 months
Interval 3.5 to 9.2
|
4.1 months
Interval 2.8 to 6.1
|
3.7 months
Interval 3.5 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 12 months after the FPFVPopulation: Analysis population consist of the Full Analysis Set, which included all patients who received at least one dose of binimetinib or ribociclib and was used for the analysis of all endpoints unless noted otherwise.
To assess clinical safety as per RECIST 1.1. Evaluation will occur continuously throughout the trial until progression, or death due to underlying cancer.
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=41 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) - Phase ll
|
11.3 months
Interval 9.3 to 14.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 12 months after the FPFVPopulation: Analysis population consist of the Full Analysis Set, which included all patients who received at least one dose of binimetinib or ribociclib and was used for the analysis of all endpoints unless noted otherwise.
To assess clinical safety according to RECIST 1.1. Evaluation will occur continuously throughout the trial until progression, or death due to underlying cancer.
Outcome measures
| Measure |
Phase 1b 28-Day MEK162 45mg + LEE011 200mg
n=41 Participants
MEK162 45mg + LEE011 200mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 250mg
MEK162 45mg+LEE011 250mg
|
Phase 1b 28-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 28-Day MEK162 45mg+LEE011 300mg
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 200mg
MEK162 30mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
Phase 1b 21-Day MEK162 30mg+LEE011 300mg
MEK162 30mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 300mg
MEK162 45mg+LEE011 300mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 450mg
MEK162 45mg+LEE011 450mg
|
Phase 1b 21-Day MEK162 45mg+LEE011 600mg
MEK162 45mg+LEE011 600mg
|
Phase 2: MEK162 45mg+LEE011 200mg
MEK162 45mg+LEE011 200mg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response (BOR) - Phase II
Complete Response
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response (BOR) - Phase II
Partial Response
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response (BOR) - Phase II
Stable Disease
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response (BOR) - Phase II
Progressive Disease
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response (BOR) - Phase II
Non-CR/Non-PD
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response (BOR) - Phase II
Unknown
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1b - 28 Day MEK162 45mg+LEE011 200mg
Serious events: 8 serious events
Other events: 16 other events
Deaths: 3 deaths
Phase 1b - 28 Day MEK162 45mg+LEE011 250mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1b - 28 Day MEK162 30mg+LEE011 300mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 1b - 28 Day MEK162 45mg+LEE011 300mg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1b - 21 Day MEK162 30mg+LEE011 200mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1b - 21 Day MEK162 45mg+LEE011 200mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1b - 21 Day MEK162 30mg+LEE011 300mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 1b - 21 Day MEK162 45mg+LEE011 300mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1b - 21 Day MEK162 45mg+LEE011 450mg
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase 1b - 21 Day MEK162 45mg+LEE011 600mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 2 - Dose Expansion Phase
Serious events: 22 serious events
Other events: 41 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Phase 1b - 28 Day MEK162 45mg+LEE011 200mg
n=16 participants at risk
MEK162 45mg BID+LEE011 200mg QD
|
Phase 1b - 28 Day MEK162 45mg+LEE011 250mg
n=3 participants at risk
MEK162 45mg BID+LEE011 250mg QD
|
Phase 1b - 28 Day MEK162 30mg+LEE011 300mg
n=4 participants at risk
MEK162 30mg BID+LEE011 300mg QD
|
Phase 1b - 28 Day MEK162 45mg+LEE011 300mg
n=6 participants at risk
MEK162 45mg BID+LEE011 300mg QD
|
Phase 1b - 21 Day MEK162 30mg+LEE011 200mg
n=5 participants at risk
MEK162 30mg BID+LEE011 200mg QD
|
Phase 1b - 21 Day MEK162 45mg+LEE011 200mg
n=6 participants at risk
MEK162 45mg BID+LEE011 200mg QD
|
Phase 1b - 21 Day MEK162 30mg+LEE011 300mg
n=2 participants at risk
MEK162 30mg BID+LEE011 300mg QD
|
Phase 1b - 21 Day MEK162 45mg+LEE011 300mg
n=4 participants at risk
MEK162 45mg BID+LEE011 300mg QD
|
Phase 1b - 21 Day MEK162 45mg+LEE011 450mg
n=9 participants at risk
MEK162 45mg BID+LEE011 450mg QD
|
Phase 1b - 21 Day MEK162 45mg+LEE011 600mg
n=6 participants at risk
MEK162 45mg BID+LEE011 600mg QD
|
Phase 2 - Dose Expansion Phase
n=41 participants at risk
The dose-expansion phase was initiated with a newly recruited group of patients.
Binimetinib 45 mg BID + ribociclib 200 mg QD on 28-day schedule
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Vascular disorders
Embolism
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
40.0%
2/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
9.8%
4/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
General disorders
Pain
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
1/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Nervous system disorders
Pyrexia
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
2/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
9.8%
4/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
General disorders
Face oedema
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Investigations
Blood creatine phosphokinase
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Investigations
Neutrophil
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
1/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Nervous system disorders
Slow speech
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Nervous system disorders
Hemiparesis
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
1/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Nervous system disorders
Seizure
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Eye disorders
Retinal detachment
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Small intestinal
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
1/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
1/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
4.9%
2/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Chills
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Renal and urinary disorders
Micturition frequency
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
1/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
4.9%
2/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Infections and infestations
Lung infection
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
4.9%
2/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Infections and infestations
Infection
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
Other adverse events
| Measure |
Phase 1b - 28 Day MEK162 45mg+LEE011 200mg
n=16 participants at risk
MEK162 45mg BID+LEE011 200mg QD
|
Phase 1b - 28 Day MEK162 45mg+LEE011 250mg
n=3 participants at risk
MEK162 45mg BID+LEE011 250mg QD
|
Phase 1b - 28 Day MEK162 30mg+LEE011 300mg
n=4 participants at risk
MEK162 30mg BID+LEE011 300mg QD
|
Phase 1b - 28 Day MEK162 45mg+LEE011 300mg
n=6 participants at risk
MEK162 45mg BID+LEE011 300mg QD
|
Phase 1b - 21 Day MEK162 30mg+LEE011 200mg
n=5 participants at risk
MEK162 30mg BID+LEE011 200mg QD
|
Phase 1b - 21 Day MEK162 45mg+LEE011 200mg
n=6 participants at risk
MEK162 45mg BID+LEE011 200mg QD
|
Phase 1b - 21 Day MEK162 30mg+LEE011 300mg
n=2 participants at risk
MEK162 30mg BID+LEE011 300mg QD
|
Phase 1b - 21 Day MEK162 45mg+LEE011 300mg
n=4 participants at risk
MEK162 45mg BID+LEE011 300mg QD
|
Phase 1b - 21 Day MEK162 45mg+LEE011 450mg
n=9 participants at risk
MEK162 45mg BID+LEE011 450mg QD
|
Phase 1b - 21 Day MEK162 45mg+LEE011 600mg
n=6 participants at risk
MEK162 45mg BID+LEE011 600mg QD
|
Phase 2 - Dose Expansion Phase
n=41 participants at risk
The dose-expansion phase was initiated with a newly recruited group of patients.
Binimetinib 45 mg BID + ribociclib 200 mg QD on 28-day schedule
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Oedema peripheral
|
43.8%
7/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
66.7%
2/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
2/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
3/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
20.0%
1/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
2/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
22.2%
2/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
43.9%
18/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
General disorders
Fatigue
|
37.5%
6/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
1/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
75.0%
3/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
60.0%
3/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
83.3%
5/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
100.0%
2/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
3/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
36.6%
15/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
General disorders
Pyrexia
|
12.5%
2/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
66.7%
2/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
40.0%
2/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
2/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
22.2%
2/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
26.8%
11/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
General disorders
Chills
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
1/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
40.0%
2/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
14.6%
6/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Blood and lymphatic system disorders
Aeaemia
|
31.2%
5/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
66.7%
2/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
2/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
66.7%
4/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
40.0%
2/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
44.4%
4/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
24.4%
10/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.8%
3/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
1/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
2/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
44.4%
4/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
3/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
12.2%
5/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
6/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
66.7%
2/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
75.0%
3/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
66.7%
4/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
80.0%
4/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
3/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
100.0%
2/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
53.7%
22/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Diarrhoea
|
37.5%
6/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
66.7%
2/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
2/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
66.7%
4/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
60.0%
3/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
66.7%
4/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
100.0%
2/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
2/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
3/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
83.3%
5/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
51.2%
21/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
4/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
100.0%
3/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
100.0%
4/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
3/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
60.0%
3/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
1/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
22.2%
2/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
34.1%
14/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Constipation
|
18.8%
3/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
1/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
2/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
3/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
3/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
19.5%
8/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
100.0%
2/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
12.2%
5/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
20.0%
1/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
1/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
3/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
9.8%
4/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
4/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
9.8%
4/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
20.0%
1/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
7.3%
3/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
4/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
2/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
1/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
3/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
7.3%
3/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
22.2%
2/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
1/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Cardiac disorders
Angina pectoris
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Cardiac disorders
Cardio-respiratiory arrest
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Eye disorders
Chorioretinopathy
|
18.8%
3/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Eye disorders
Retinal detachment
|
18.8%
3/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
20.0%
1/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
14.6%
6/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Eye disorders
Vision blurred
|
12.5%
2/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
2/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
3/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Eye disorders
Retinopathy
|
12.5%
2/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
20.0%
1/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Eye disorders
Macular oedema
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
22.2%
2/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
12.2%
5/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Eye disorders
Subretinal fluid
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
20.0%
1/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
1/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
12.2%
5/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Eye disorders
Dry eye
|
12.5%
2/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Eye disorders
Cataract
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
50.0%
1/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Eye disorders
Chorioretinal disorder
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Eye disorders
Periorbital oedema
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Eye disorders
Retinal disorder
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
2/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
40.0%
2/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
33.3%
2/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
2/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
20.0%
1/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Gastritis
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
Gastrointestinal disorders
Glossodynia
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
General disorders
Face oedema
|
18.8%
3/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
25.0%
1/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
2.4%
1/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
General disorders
Pain
|
6.2%
1/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
11.1%
1/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
|
General disorders
Astenia
|
0.00%
0/16 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/3 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/5 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/2 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/4 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
0.00%
0/9 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
16.7%
1/6 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
7.3%
3/41 • Adverse Events (AE) were collected during the study, which began in June 2013 and concluded February 2018. After signing of the informed consent until 30 days after study treatment discontinuation.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of the sponsor's agreements with its investigators may vary. However, the sponsor does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e., data from all sites) in the clinical trials.
- Publication restrictions are in place
Restriction type: OTHER