Trial Outcomes & Findings for Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia (NCT NCT00607997)
NCT ID: NCT00607997
Last Updated: 2017-06-28
Results Overview
Combined remission rate (complete remission \[CR\] + complete remission with incomplete platelet recovery \[CRp\]) of vosaroxin of patients ≥ 60 years old with previously untreated (de novo or secondary) AML are presented by treatment group for all treated analysis set. Per IWG criteria, a CR requires bone marrow blasts \< 5%, absolute neutrophil count (ANC) \> 1000 cells/uL, and platelet (plt) count \> 100,000 plt/uL. The criteria for CRp are the same as those for CR, except for platelet count \<= 100,000 lt/uL. Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (Morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
113 participants
Primary outcome timeframe
2 years
Results posted on
2017-06-28
Participant Flow
Participant milestones
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
Schedule C (implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
35
|
29
|
20
|
|
Overall Study
COMPLETED
|
2
|
8
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
27
|
27
|
24
|
16
|
Reasons for withdrawal
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
Schedule C (implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
6
|
20
|
14
|
10
|
|
Overall Study
Death
|
8
|
5
|
2
|
5
|
|
Overall Study
Adverse Event
|
3
|
1
|
2
|
0
|
|
Overall Study
Physician Decision
|
4
|
1
|
0
|
0
|
|
Overall Study
Relapse, recurrent illness
|
4
|
0
|
2
|
0
|
|
Overall Study
Other without explanation
|
2
|
0
|
4
|
1
|
Baseline Characteristics
Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=29 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=35 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
n=29 Participants
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
n=20 Participants
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
74.1 years
STANDARD_DEVIATION 6.20 • n=99 Participants
|
74.2 years
STANDARD_DEVIATION 5.85 • n=107 Participants
|
70.5 years
STANDARD_DEVIATION 5.68 • n=206 Participants
|
76.5 years
STANDARD_DEVIATION 5.70 • n=7 Participants
|
73.6 years
STANDARD_DEVIATION 6.14 • n=31 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
40 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
73 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
110 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
102 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The all treated analysis set Included all enrolled patients who received any amount of vosaroxin.
Combined remission rate (complete remission \[CR\] + complete remission with incomplete platelet recovery \[CRp\]) of vosaroxin of patients ≥ 60 years old with previously untreated (de novo or secondary) AML are presented by treatment group for all treated analysis set. Per IWG criteria, a CR requires bone marrow blasts \< 5%, absolute neutrophil count (ANC) \> 1000 cells/uL, and platelet (plt) count \> 100,000 plt/uL. The criteria for CRp are the same as those for CR, except for platelet count \<= 100,000 lt/uL. Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (Morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse.
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=29 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=35 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
n=29 Participants
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
n=20 Participants
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
n=113 Participants
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions
|
41.4 percentage of patients
Interval 23.5 to 61.1
|
25.7 percentage of patients
Interval 12.5 to 43.3
|
34.5 percentage of patients
Interval 17.9 to 54.3
|
25.0 percentage of patients
Interval 8.7 to 49.1
|
31.9 percentage of patients
Interval 24.3 to 41.3
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All treated analysis set
The censor date was the last known alive date without report of relapse.
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=29 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=35 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
n=29 Participants
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
n=20 Participants
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
n=113 Participants
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
Leukemia-free Survival (LFS)
|
9.8 Months
Interval 2.4 to 15.7
|
10.9 Months
Interval 2.9 to 15.0
|
5.5 Months
Interval 1.5 to 7.3
|
4.9 Months
Interval 1.3 to 4.9
|
6.1 Months
Interval 4.9 to 9.8
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All treated patients
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=29 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=35 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
n=29 Participants
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
n=20 Participants
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
n=113 Participants
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
Overall Survival
|
8.6 Months
Interval 1.2 to 14.7
|
5.8 Months
Interval 1.9 to 10.1
|
7.8 Months
Interval 3.4 to 12.2
|
5.6 Months
Interval 1.8 to 11.1
|
7.0 Months
Interval 4.0 to 9.2
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 9 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.
Pharmacokinetic Parameters (Cmax) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1 Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=10 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=9 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
n=6 Participants
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
n=8 Participants
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
Pharmacokinetics Day 1 - Cmax (ng/mL)
|
3028 ng/mL
Standard Deviation 48.7
|
2450 ng/mL
Standard Deviation 47.8
|
2865 ng/mL
Standard Deviation 47.8
|
3328 ng/mL
Standard Deviation 69.0
|
—
|
SECONDARY outcome
Timeframe: Day 4Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4 for 5 patients in Schedule C, and for 8 patients in Schedule C .
Pharmacokinetic Parameters by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) on Day 4 Please note that N, mean and CV% are reported, but CV% is not an option in the drop down menu. So Standard Deviation is really CV% in the table.
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=5 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=8 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
Pharmacokinetics Day 4 Cmax (ng/mL)
|
5792 ng/mL
Standard Deviation 114.9
|
4148 ng/mL
Standard Deviation 98.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 and 60 daysPopulation: All treated analysis set
Mortality of those patients enrolled in the study and receiving intervention
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=29 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=35 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
n=29 Participants
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
n=20 Participants
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
n=113 Participants
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
All Cause Mortality
30-Day
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
12 Participants
|
|
All Cause Mortality
60-Day
|
11 Participants
|
13 Participants
|
5 Participants
|
6 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 9 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.
Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1 Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=10 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=9 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
n=6 Participants
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
n=8 Participants
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL)
AUC0-72 (hr.ng/mL)
|
36721 hr*ng/mL
Standard Deviation 21.1
|
40092 hr*ng/mL
Standard Deviation 28.7
|
37401 hr*ng/mL
Standard Deviation 13.9
|
38086 hr*ng/mL
Standard Deviation 28.0
|
—
|
|
Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL)
AUCinf (hr.ng/mL)
|
41903 hr*ng/mL
Standard Deviation 27.3
|
47228 hr*ng/mL
Standard Deviation 28.7
|
44848 hr*ng/mL
Standard Deviation 13.0
|
43838 hr*ng/mL
Standard Deviation 31.8
|
—
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.
Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1 Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=10 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=8 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
n=6 Participants
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
n=8 Participants
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr)
t1/2 (hr)
|
22.51 hr
Standard Deviation 36.6
|
27.29 hr
Standard Deviation 21.2
|
28.27 hr
Standard Deviation 32.1
|
23.57 hr
Standard Deviation 25.2
|
—
|
|
Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr)
MRTinf (hr)
|
30.56 hr
Standard Deviation 41.4
|
37.57 hr
Standard Deviation 23.5
|
37.16 hr
Standard Deviation 36.8
|
32.10 hr
Standard Deviation 27.0
|
—
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.
Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1 Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=10 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=8 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
n=6 Participants
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
n=8 Participants
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
Pharmacokinetics Day 1 - CL (L/hr)
|
3.643 L/hr
Standard Deviation 30.0
|
3.389 L/hr
Standard Deviation 33.4
|
3.235 L/hr
Standard Deviation 15.2
|
4.538 L/hr
Standard Deviation 25.3
|
—
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.
Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1 Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=10 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=8 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
n=6 Participants
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
n=8 Participants
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
Pharmacokinetics Day 1 - Vss (L)
|
107.9 L
Standard Deviation 40.4
|
129.9 L
Standard Deviation 50.2
|
116.6 L
Standard Deviation 28.5
|
139.2 L
Standard Deviation 21.1
|
—
|
SECONDARY outcome
Timeframe: Day 4Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4, for 5 patients in Schedule C, and for 8 patients in Schedule C.
Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4 Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. Standard Deviation is really CV% in the table.
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=5 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=8 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL)
AUC0-72 (hr.ng/mL)
|
35125 hr*ng/mL
Standard Deviation 23.8
|
43667 hr*ng/mL
Standard Deviation 32.3
|
—
|
—
|
—
|
|
Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL)
AUCinf (hr.ng/mL)
|
40539 hr*ng/mL
Standard Deviation 26.9
|
46462 hr*ng/mL
Standard Deviation 37.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data, for 5 patients in Schedule C, and for 7 patients in Schedule C.
Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4 Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The Standard Deviation is really CV% in the table.
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=5 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=7 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr)
t1/2 (hr)
|
23.52 hr
Standard Deviation 27.6
|
20.41 hr
Standard Deviation 28.7
|
—
|
—
|
—
|
|
Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr)
MRTinf (hr)
|
31.83 hr
Standard Deviation 35.7
|
27.79 hr
Standard Deviation 24.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4, for 5 patients in Schedule C, and for 7 patients in Schedule C.
Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4 Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=5 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=7 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
Pharmacokinetics Day 4 - CL (L/hr)
|
4.387 L/hr
Standard Deviation 30.3
|
4.882 L/hr
Standard Deviation 28.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data for Day 4, for 5 patients in Schedule C, and for 7 patients in Schedule C.
Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4 Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Outcome measures
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=5 Participants
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=7 Participants
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
Total
Schedule A, B and C combined
|
|---|---|---|---|---|---|
|
Pharmacokinetics Day 4 - Vss (L)
|
137.3 L
Standard Deviation 39.5
|
132.7 L
Standard Deviation 34.0
|
—
|
—
|
—
|
Adverse Events
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
Serious events: 25 serious events
Other events: 29 other events
Deaths: 25 deaths
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
Serious events: 29 serious events
Other events: 35 other events
Deaths: 31 deaths
Schedule C: 72 mg/m2 on Days 1 and 4
Serious events: 21 serious events
Other events: 29 other events
Deaths: 28 deaths
Schedule C: 90 mg/m2 on Days 1 and 4
Serious events: 17 serious events
Other events: 20 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=29 participants at risk
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=35 participants at risk
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
n=29 participants at risk
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
n=20 participants at risk
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.1%
6/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
30.0%
6/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Cardio-Respiratory arrest
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Myocardial ischaemia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Intestinal functional disorder
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Neutropenic colitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Oesophagitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Stomatitis
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Death
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Multi-Organ failure
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Non-Cardiac chest pain
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Pyrexia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Bacteraemia
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Cellulitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Cellulitis orbital
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Enterococcal bacteraemia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Pneumonia
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
31.4%
11/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
24.1%
7/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
4/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Pneumonia fungal
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Pseudomonal sepsis
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Sepsis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Septic shock
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Sinusitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Sinusitis fungal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Staphylococcal bacteraemia
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Staphylococcal infection
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Staphylococcal sepsis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Streptococcal bacteraemia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Streptococcal sepsis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
subdural haemorrhage
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Failure to thrive
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour lysis syndrome
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Convulsion
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Grand mal convulsion
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Neuropathy peripheral
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Confusional state
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Suicidal ideation
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Renal failure
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Renal failure acute
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Deep vein thrombosis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
Other adverse events
| Measure |
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15
n=29 participants at risk
The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
|
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8
n=35 participants at risk
Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
|
Schedule C: 72 mg/m2 on Days 1 and 4
n=29 participants at risk
Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
|
Schedule C: 90 mg/m2 on Days 1 and 4
n=20 participants at risk
Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
|
|---|---|---|---|---|
|
Eye disorders
Erythema of eyelid
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Eye Oedema
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Madarosis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Ocular hyperaemia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Anorectal disorder
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Aptyalism
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Ascites
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Bowel sounds abnormal
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Breath odour
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Caecitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Chapped lips
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Colonic Pseudo-obstruction
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Constipation
|
41.4%
12/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
37.1%
13/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
4/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Diarrhoea
|
82.8%
24/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
77.1%
27/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
69.0%
20/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
70.0%
14/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Diverticulum
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Dry mouth
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Dyspepsia
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Dysphagia
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
25.7%
9/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Oral mucosal discolouration
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Oral mucosal petechiae
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Oral pain
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
30.0%
6/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Oral soft tissue disorder
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Palatal disorder
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Perianal erythema
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Poor dental condition
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Proctalgia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Rectal fissure
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Rectal spasm
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Stomatitis
|
62.1%
18/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
54.3%
19/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
51.7%
15/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
55.0%
11/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Helicobacter pylori identification test positive
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Hepatitis a antibody positive
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
International normalised ratio increased
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Liver function test abnormal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Liver scan abnormal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Lymph node palpable
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Nuclear magnetic resonance imaging brain abnormal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Oxygen consumption increased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Prostate examination abnormal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Prothrombin level increased
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Prothrombin time prolonged
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Pulse pressure decreased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Pulse pressure increased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Radial pulse abnormal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Respiratory rate increased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Skin turgor decreased
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Sputum culture positive
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Transaminases increased
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Troponin i increased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Urine colour abnormal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Urine output decreased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Weight decreased
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Weight increased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
White blood cell count decreased
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
X-Ray abnormal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Xanthochromia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Urinary incontinence
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Enlarged uvula
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Tongue blistering
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Tongue discolouration
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Tongue haematoma
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Heart rate irregular
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Residual urine
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Bundle branch block
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Bundle branch block left
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Cardiac failure congestive
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Cardiomegaly
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Mitral valve Disease
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Mitral valve incompetence
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Myocardial infraction
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Palpitations
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Pericardial cyst
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Pericardial effusion
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Sinus bradycardia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Sinus Tachycardia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Tachycardia
|
37.9%
11/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
40.0%
14/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
25.0%
5/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Ventricular extrasystoles
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Ear and labyrinth disorders
Deafness bilateral
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Ear and labyrinth disorders
Ear congestion
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Ear and labyrinth disorders
Ear pain
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Ear and labyrinth disorders
Eustachian tube patulous
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Ear and labyrinth disorders
Tinnitus
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Conjunctival discolouration
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Conjunctival haemorrhage
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Dry eye
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Anaemia
|
41.4%
12/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
54.3%
19/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
65.5%
19/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
60.0%
12/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Coagulopathy
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
34.5%
10/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
54.3%
19/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
48.3%
14/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
25.0%
5/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Hilar lymphadenopathy
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Lymph node calcification
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Neutropenia
|
41.4%
12/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
25.7%
9/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
27.6%
8/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
25.0%
5/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
41.4%
12/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
68.6%
24/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
69.0%
20/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
60.0%
12/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Acute myocardial infraction
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Angina pectoris
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Atrial fibrillation
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
4/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Cardiac disorders
Bradycardia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Ocular icterus
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Vision blurred
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Visual disturbance
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Abdominal distension
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
30.0%
6/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain
|
31.0%
9/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.1%
6/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Faecal incontinence
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Gingivitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Glossodynia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Haematochezia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Haemorrhoids
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
7/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Leukoplakia oral
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Lip dry
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Lip haemorrhage
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Lip pain
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Malabsorption
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Melaena
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
75.9%
22/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
60.0%
21/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
86.2%
25/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
55.0%
11/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Odynophagia
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Oedema mouth
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Oesophageal disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Oesophageal Spasm
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Toothache
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Vomiting
|
55.2%
16/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
28.6%
10/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
51.7%
15/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
30.0%
6/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Application site hypersensitivity
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Asthenia
|
31.0%
9/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
40.0%
14/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Axillary pain
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Catheter related complication
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Catheter site erythema
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Catheter site excoriation
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Catheter site haematoma
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Catheter site haemorrhage
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Catheter site inflammation
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Catheter site oedema
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Catheter site pain
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Catheter site related reaction
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Catheter Thrombosis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Chest discomfort
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Chest pain
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Chills
|
27.6%
8/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
34.3%
12/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
27.6%
8/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
30.0%
6/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Discomfort
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Early Satiety
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Face Oedema
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Facial pain
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Fatigue
|
51.7%
15/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
57.1%
20/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
41.4%
12/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
35.0%
7/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Feeling cold
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Gait disturbance
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Generalized oedema
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Induration
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Infusion site pain
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Injection site bruising
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Injection site reaction
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Malaise
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Mucosal Inflammation
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Mucous membrane disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Multi-Organ failure
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Nodule
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Non-Cardiac chest pain
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Oedema
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Oedema peripheral
|
58.6%
17/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
48.6%
17/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
51.7%
15/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
45.0%
9/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Pain
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
24.1%
7/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Performance status decreased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Peripheral coldness
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Pyrexia
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
25.7%
9/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
24.1%
7/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
35.0%
7/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Suprapubic pain
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Swelling
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
General disorders
Tenderness
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Hepatobiliary disorders
Cholecystitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Hepatobiliary disorders
Cholelithiasis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Hepatobiliary disorders
Jaundice
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Abscess
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Acinetobacter bacteraemia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Anorectal infection bacterial
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Bacteraemia
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Bacterial infection
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Bacteroides bacteraemia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Bronchiolitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Bronchitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Candidiasis
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Catheter related infection
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Catheter site infection
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Cellulitis
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Central line infection
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Chronic Sinusitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Clostridium difficile colitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Diverticulitis
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Enterococcal bacteraemia
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Enterococcal infection
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Folliculitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Fungaemia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Fungal infection
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Fungal rash
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Fusarium infection
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Gingival infection
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Herpes simplex
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Infection
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Lobar pneumonia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Localized infection
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Lung infection
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Parotitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Pneumonia
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Pneumonia fungal
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Pseudomonal sepsis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Pseudomonas infection
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Rhinitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Sinusitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Skin infection
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Staphylococcal bacteraemia
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Staphylococcal infection
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Urinary tract infection
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Urinary tract infection enterococcal
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Infections and infestations
Vaginal candidiasis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Anaphylactic transfusion reaction
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Contusion
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Fall
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Skin laceration
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Tracheal deviation
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Wound
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Bacteria sputum identified
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Bacteria urine identified
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Bacterial culture positive
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Blood alkaline phosphatase increased
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Blood creatinine increased
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Blood culture positive
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Blood glucose increased
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Blood testosterone decreased
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Blood urea increased
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Blood uric acid increased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Body temperature decreased
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Breath sounds abnormal
|
24.1%
7/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.1%
6/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
C-Reactive protein increased
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Cardiac murmur
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Chest x-ray abnormal
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Clostridium difficile toxin test positive
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Culture urine positive
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Ejection fraction decreased
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Electrocardiogram qrs complex abnormal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Electrocardiogram qt corrected interval prolonged
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Electrocardiogram st segment abnormal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Electrocardiogram st segment depression
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Electrocardiogram st-t change
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Electrocardiogram st-t segment abnormal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Electrocardiogram t wave abnormal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Electrocardiogram t wave inversion
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Anorexia
|
72.4%
21/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
51.4%
18/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
58.6%
17/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
55.0%
11/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Dehydration
|
24.1%
7/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
7/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
4/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Diabetes mellitus insulin-dependent
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Fluid overload
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
7/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
27.6%
8/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
31.0%
9/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
4/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
72.4%
21/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
54.3%
19/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
58.6%
17/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
70.0%
14/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
51.7%
15/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
40.0%
14/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
48.3%
14/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
35.0%
7/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.1%
6/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
44.8%
13/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
22.9%
8/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
30.0%
6/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Malnutrition
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Metabolism and nutrition disorders
Oral intake reduced
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
7/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Osteosclerosis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
24.1%
7/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Spondylolysis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour lysis syndrome
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Ageusia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Aphasia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Carotid artery occlusion
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Convulsion
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Coordination abnormal
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Dizziness
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
7/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
24.1%
7/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
4/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Dysarthria
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Dysgeusia
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
25.0%
5/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Encephalopathy
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Headache
|
34.5%
10/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
25.7%
9/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
31.0%
9/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Hypoaesthesia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Hypogeusia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Intention tremor
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Lethargy
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Neuralgia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Neuropathy peripheral
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Parosmia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Periventricular leukomalacia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Restless legs syndrome
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Somnolence
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Syncope
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Transient ischaemic attack
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Tremor
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Agitation
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Anxiety
|
24.1%
7/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
40.0%
14/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
41.4%
12/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
4/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Apathy
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Confusional state
|
27.6%
8/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
25.7%
9/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
24.1%
7/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Delirium
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Delusion
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Depression
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Dysthymic disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Flat affect
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Hallucination
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Insomnia
|
41.4%
12/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
37.1%
13/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
37.9%
11/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Mental disorder
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Restlessness
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Dysuria
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Haematuria
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
31.4%
11/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Incontinence
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Nocturia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Pollakiuria
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Renal cyst
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Renal failure acute
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Renal mass
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Urinary retention
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Reproductive system and breast disorders
Penile oedema
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Reproductive system and breast disorders
Scrotal erythema
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Reproductive system and breast disorders
Vulval disorder
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.8%
13/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
31.4%
11/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
37.9%
11/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
30.0%
6/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmalgia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
37.9%
11/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
40.0%
14/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
37.9%
11/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
30.0%
6/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic oedema
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
24.1%
7/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
37.1%
13/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
27.6%
8/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
25.0%
5/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
22.9%
8/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.1%
6/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
24.1%
7/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.1%
6/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
37.9%
11/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
34.5%
10/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
22.9%
8/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
4/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.1%
6/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
41.4%
12/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
22.9%
8/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
44.8%
13/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
25.0%
5/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Blister
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
27.6%
8/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.0%
7/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
27.6%
8/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
25.0%
5/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Perivascular dermatitis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
27.6%
8/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
31.4%
11/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.2%
5/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
14.3%
5/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.1%
7/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
22.9%
8/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
31.0%
9/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
15.0%
3/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Surgical and medical procedures
Sinus operation
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Arterial disorder
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Deep vein thrombosis
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Flushing
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Haematoma
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.7%
2/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Hot flush
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Hypertension
|
20.7%
6/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
11.4%
4/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.3%
3/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Hypotension
|
37.9%
11/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
31.4%
11/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
34.5%
10/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
30.0%
6/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Orthostatic hypotension
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Pallor
|
13.8%
4/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
8.6%
3/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
6.9%
2/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Phlebitis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Vascular disorders
Thrombosis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
3.4%
1/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
5.0%
1/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Investigations
Bacteria tissue specimen identified
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
2.9%
1/35 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
0.00%
0/29 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
10.0%
2/20 • Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events
|
Additional Information
Linda Neuman, Vice President, Clinical Development
Sunesis Pharmaceuticals, Inc.
Phone: (650) 266-3760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60