Trial Outcomes & Findings for Lapatinib in Combination With Vinorelbine (NCT NCT01013740)
NCT ID: NCT01013740
Last Updated: 2017-05-31
Results Overview
PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20 % increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of \>=1 new lesion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)
Results posted on
2017-05-31
Participant Flow
In the Randomized Phase (RP), participants were treated until disease progression (PD) or discontinuation of treatment due to unacceptable toxicity, withdrawal of consent, lost to follow-up, or death. After PD in the RP, participants were given the option of crossing over to the alternative treatment arm in a post-progression Cross-over Phase (CP).
Participant milestones
| Measure |
Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP
Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams \[mg\]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m\^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
|
Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP
Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m\^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
75
|
|
Overall Study
Ongoing
|
0
|
0
|
|
Overall Study
COMPLETED
|
26
|
56
|
|
Overall Study
NOT COMPLETED
|
11
|
19
|
Reasons for withdrawal
| Measure |
Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP
Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams \[mg\]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m\^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
|
Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP
Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m\^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
10
|
|
Overall Study
study close / terminated : done in error
|
2
|
1
|
|
Overall Study
Missing
|
2
|
1
|
|
Overall Study
Ongoing: Study records not completed
|
0
|
2
|
Baseline Characteristics
Lapatinib in Combination With Vinorelbine
Baseline characteristics by cohort
| Measure |
Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP
n=37 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams \[mg\]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m\^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
|
Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP
n=75 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m\^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 Years
STANDARD_DEVIATION 10.90 • n=5 Participants
|
57.7 Years
STANDARD_DEVIATION 10.23 • n=7 Participants
|
57.6 Years
STANDARD_DEVIATION 10.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
36 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander & White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)Population: ITT Population: participants who were randomized to study treatment, regardless of whether they actually received study medication
PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20 % increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of \>=1 new lesion.
Outcome measures
| Measure |
Lapatinib Plus Capecitabine
n=37 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams \[mg\]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m\^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
|
Lapatinib Plus Vinorelbine
n=75 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m\^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
|
|---|---|---|
|
Progression Free Survival (PFS) in the Randomized Phase
|
6.2 months
Interval 4.4 to 8.3
|
6.2 months
Interval 4.2 to 8.8
|
SECONDARY outcome
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)Population: ITT Population
OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions \[TLs\]) or partial response (PR: a \>=30% decrease in the sum of the longest diameter \[LD\] of the TLs, taking as reference the baseline sum LD) as assessed by the investigator as the best OR.
Outcome measures
| Measure |
Lapatinib Plus Capecitabine
n=37 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams \[mg\]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m\^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
|
Lapatinib Plus Vinorelbine
n=75 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m\^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
|
|---|---|---|
|
Number of Participants With Overall Response (OR), as Assessed by the Investigator in the Randomized Phase
|
13 participants
|
15 participants
|
SECONDARY outcome
Timeframe: From the date of randomization until death (average of 55 study weeks)Population: ITT Population
OS is defined as the time from randomization to the date of death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.
Outcome measures
| Measure |
Lapatinib Plus Capecitabine
n=37 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams \[mg\]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m\^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
|
Lapatinib Plus Vinorelbine
n=75 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m\^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
|
|---|---|---|
|
Overall Survival (OS)
|
19.4 months
Interval 16.4 to 27.2
|
24.3 months
Interval 16.4 to
The upper limit of the 95% confidence interval (CI) could not be determined (not reached) because there were not enough events to be able to calculate the upper limit of the CI.
|
SECONDARY outcome
Timeframe: From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 27 study weeks)Population: ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response.
DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a \>=20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of \>=1 new lesion) or death, if sooner. CR=the disappearance of all TLs. PR=a \>=30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.
Outcome measures
| Measure |
Lapatinib Plus Capecitabine
n=13 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams \[mg\]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m\^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
|
Lapatinib Plus Vinorelbine
n=15 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m\^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
|
|---|---|---|
|
Duration of Response (DOR) in the Randomized Phase
|
10.8 months
Interval 4.3 to
The upper limit of the 95% confidence interval (CI) could not be determined (not reached) because there were not enough events to be able to calculate the upper limit of the CI.
|
6.7 months
Interval 4.6 to 8.3
|
SECONDARY outcome
Timeframe: From randomization until the time of the first documented confirmed CR or PR (average of 27 study weeks)Population: ITT Population. Only participants with a confirmed CR or PR were assessed for time to response.
Time to response is defined as the time from randomization until the first documented evidence of CR (the disappearance of all TLs) or PR (a \>=30% decrease in the sum of the LD of the TLs, taking as a reference the basline sum LD) (whichever status is recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed.
Outcome measures
| Measure |
Lapatinib Plus Capecitabine
n=13 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams \[mg\]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m\^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
|
Lapatinib Plus Vinorelbine
n=15 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m\^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
|
|---|---|---|
|
Time to Response in the Randomized Phase
|
9.3 weeks
Interval 9.1 to 10.0
|
9.4 weeks
Interval 9.0 to 10.1
|
SECONDARY outcome
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)Population: ITT Population
CB is defined as the the number of participants achieving either a confirmed CR or PR or having stable disease (SD) for at least 24 weeks (i.e., approximately 6 months). CR=the disappearance of all TLs. PR=a \>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD=at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of \>=1 new lesion). Participants with unknown or missing responses were treated as non-responders.
Outcome measures
| Measure |
Lapatinib Plus Capecitabine
n=37 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams \[mg\]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m\^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
|
Lapatinib Plus Vinorelbine
n=75 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m\^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
|
|---|---|---|
|
Number of Participants With Clinical Benefit (CB) in the Randomized Phase
|
18 participants
|
29 participants
|
SECONDARY outcome
Timeframe: Days 1 and 8; 0 to 24 hours post-doseAUC-tau is defined as the area under the concentration-time curve over a dosing interval at steady state, where tau is the length of the dosing interval. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. Pharmacokinetic (PK) parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 8; 0 to 24 hours post-doseCmax is defined as the maximum observed plasma or serum concentration after administration of the drug. PK parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 55 study weeks)Population: Safety Population: participants who received at least one dose of study medication, based on the actual treatment received
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grades: 0 = no AE or within normal limits; 1 = mild AE; 2 = moderate AE; 3 = severe and undesirable AE; 4 = life-threatening or disabling AE; 5 = death related to AE.
Outcome measures
| Measure |
Lapatinib Plus Capecitabine
n=37 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams \[mg\]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m\^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
|
Lapatinib Plus Vinorelbine
n=75 Participants
Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m\^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
|
|---|---|---|
|
Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)
Helicobacter gastritis, Grade 4
|
1 participants
|
0 participants
|
|
Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)
Neutropenia, Grade 4
|
0 participants
|
9 participants
|
|
Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)
Leukopenia, Grade 4
|
0 participants
|
1 participants
|
|
Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)
Febrile neutropenia, Grade 4
|
0 participants
|
1 participants
|
|
Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)
Mucosal inflammation, Grade 4
|
0 participants
|
1 participants
|
|
Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)
Pulmonary embolism, Grade 4
|
0 participants
|
1 participants
|
|
Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)
Intestinal obstruction, Grade 5
|
0 participants
|
1 participants
|
Adverse Events
Randomized Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
Randomized Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
Serious events: 25 serious events
Other events: 72 other events
Deaths: 0 deaths
Crossover Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Crossover Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomized Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
n=37 participants at risk
Randomized phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
|
Randomized Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
n=75 participants at risk
Randomized phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
|
Crossover Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
n=37 participants at risk
Crossover phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
|
Crossover Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
n=17 participants at risk
Crossover phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
2/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
2/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
11.8%
2/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
13.3%
10/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
General disorders
Fatigue
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
General disorders
Pyrexia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
2/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Helicobacter gastritis
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Infection
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Product Issues
Device leakage
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Vascular disorders
Thrombosis
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
Other adverse events
| Measure |
Randomized Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
n=37 participants at risk
Randomized phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
|
Randomized Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
n=75 participants at risk
Randomized phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
|
Crossover Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
n=37 participants at risk
Crossover phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
|
Crossover Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
n=17 participants at risk
Crossover phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
17.3%
13/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
11.8%
2/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.1%
3/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
14.7%
11/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
11.8%
2/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.1%
3/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
45.3%
34/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
41.2%
7/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
4.0%
3/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Cardiac disorders
Tachycardia
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Eye disorders
Ophthalmoplegia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
9.3%
7/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
8.0%
6/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Constipation
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
8.0%
6/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Diarrhoea
|
56.8%
21/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
46.7%
35/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
18.9%
7/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
8.0%
6/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Flatulence
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Nausea
|
8.1%
3/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
26.7%
20/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
16.2%
6/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Gastrointestinal disorders
Vomiting
|
10.8%
4/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
17.3%
13/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
General disorders
Asthenia
|
13.5%
5/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
13.3%
10/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
8.1%
3/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
General disorders
Axillary pain
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
General disorders
Fatigue
|
8.1%
3/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
22.7%
17/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
11.8%
2/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
General disorders
Inflammation
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
General disorders
Influenza like illness
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
2/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
General disorders
Injection site reaction
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
General disorders
Mucosal inflammation
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
12.0%
9/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
General disorders
Oedema peripheral
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
9.3%
7/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
General disorders
Peripheral swelling
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
General disorders
Pyrexia
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
13.3%
10/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
11.8%
2/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
16.2%
6/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Abscess
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Bronchitis
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.3%
4/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Cystitis
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
2/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Herpes zoster
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.3%
4/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Oral herpes
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Paronychia
|
13.5%
5/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
2/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Pharyngitis
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Sinusitis
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
6.7%
5/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Investigations
Alanine aminotransferase increased
|
8.1%
3/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
10.7%
8/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
10.8%
4/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
11.8%
2/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Investigations
Aspartate aminotransferase increased
|
10.8%
4/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
10.7%
8/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
13.5%
5/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
11.8%
2/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Investigations
Blood alkaline phosphatase increased
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.3%
4/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
8.1%
3/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Investigations
Blood bilirubin increased
|
10.8%
4/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Investigations
Blood calcium increased
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
6.7%
5/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Investigations
Weight decreased
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.3%
4/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
16.0%
12/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.3%
4/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
3/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
12.0%
9/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
9.3%
7/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
9.3%
7/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
17.6%
3/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
6.7%
5/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.1%
3/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
10.7%
8/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
10.8%
4/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
11.8%
2/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Nervous system disorders
Dizziness
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
6.7%
5/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Nervous system disorders
Headache
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
10.7%
8/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
11.8%
2/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
6.7%
5/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Nervous system disorders
Paraesthesia
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
2/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
10.7%
8/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Psychiatric disorders
Insomnia
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.3%
4/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
12.0%
9/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
11.8%
2/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.1%
3/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.3%
4/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
4.0%
3/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
8.0%
6/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
1.3%
1/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
10.8%
4/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
2/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
1/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
64.9%
24/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
8.0%
6/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
48.6%
18/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.5%
5/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
20.0%
15/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
5.4%
2/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
2/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
|
Vascular disorders
Hot flush
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
2.7%
2/75 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
0.00%
0/37 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
|
5.9%
1/17 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
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Additional Information
Clinical Disclosure Office
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER