Trial Outcomes & Findings for Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer (NCT NCT00771810)
NCT ID: NCT00771810
Last Updated: 2017-11-13
Results Overview
Mean percentage of cycles with platelet counts below 50,000/mm3
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
During a maximum of six 3-week chemotherapy cycles
Results posted on
2017-11-13
Participant Flow
Subjects were recruited from Feb2009 to Feb2012 across 10 oncology sites.
Participant milestones
| Measure |
Placebo
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300 ug/kg
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
13
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300 ug/kg
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
Baseline Characteristics
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
n=11 Participants
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300ug/kg
n=13 Participants
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
13 participants
n=5 Participants
|
34 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During a maximum of six 3-week chemotherapy cyclesPopulation: The number of participants for analysis was the intention to treat population.
Mean percentage of cycles with platelet counts below 50,000/mm3
Outcome measures
| Measure |
Placebo
n=10 Participants
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
n=10 Participants
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300ug/kg
n=12 Participants
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3
|
20.0 Percentage of cycles
Interval 0.0 to 67.0
|
11.7 Percentage of cycles
Interval 0.0 to 50.0
|
21.5 Percentage of cycles
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: During a maximum of six 3-week chemotherapy cyclesPopulation: The number of participants for analysis was the safety population.
Number of subjects who experienced a platelet count below 50,000/mm3
Outcome measures
| Measure |
Placebo
n=10 Participants
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
n=11 Participants
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300ug/kg
n=13 Participants
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Subjects With Platelet Counts Below 50,000/mm3
|
5 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: During a maximum of six 3-week chemotherapy cyclesPopulation: The number of participants for analysis was the intention to treat population.
Mean percentage of treatment cycles where platelets counts were below 25,000/mm3
Outcome measures
| Measure |
Placebo
n=10 Participants
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
n=10 Participants
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300ug/kg
n=12 Participants
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Treatment Cycles With Platelets Counts Below 25,000/mm3
|
5.8 Percentage of cycles
Interval 0.0 to 33.3
|
0 Percentage of cycles
Interval 0.0 to 0.0
|
10.4 Percentage of cycles
Interval 0.0 to 83.3
|
SECONDARY outcome
Timeframe: During a maximum of six 3-week chemotherapy cyclesPopulation: The number of participants for analysis was the intention to treat population.
Mean percentage of cycles where projected (target) chemotherapy dose was maintained
Outcome measures
| Measure |
Placebo
n=10 Participants
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
n=10 Participants
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300ug/kg
n=12 Participants
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Chemotherapy Dose Intensity and Dose Density
Gemcitabine
|
67.6 Percentage of cycles
Interval 46.3 to 100.0
|
86.5 Percentage of cycles
Interval 61.4 to 102.3
|
71.7 Percentage of cycles
Interval 45.0 to 95.5
|
|
Chemotherapy Dose Intensity and Dose Density
Gemcitabine with Carboplatin or Cisplatin
|
76.7 Percentage of cycles
Interval 59.8 to 100.0
|
88.7 Percentage of cycles
Interval 68.0 to 99.1
|
79.5 Percentage of cycles
Interval 51.4 to 96.3
|
SECONDARY outcome
Timeframe: During a maximum of six 3-week chemotherapy cyclesPopulation: The number of participants for analysis was the safety population.
Number of subjects with a treatment emergent adverse event of lymphopenia
Outcome measures
| Measure |
Placebo
n=10 Participants
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
n=11 Participants
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300ug/kg
n=13 Participants
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Lymphopenia as Determined by Lymphocyte Count
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During a maximum of six 3-week chemotherapy cyclesPopulation: The number of participants for analysis was the safety population.
Number of subjects with a treatment emergent adverse event of neutropenia
Outcome measures
| Measure |
Placebo
n=10 Participants
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
n=11 Participants
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300ug/kg
n=13 Participants
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Neutropenia
|
7 Participants
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: During a maximum of six 3-week chemotherapy cyclesPopulation: The number of participants for analysis was the safety population.
Number of subjects with a treatment emergent adverse event of anemia
Outcome measures
| Measure |
Placebo
n=10 Participants
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
n=11 Participants
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300ug/kg
n=13 Participants
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Anemia
|
2 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: During a maximum of six 3-week chemotherapy cyclesPopulation: The number of participants for analysis was the safety population.
Number of subjects with a treatment emergent adverse event of mucositis
Outcome measures
| Measure |
Placebo
n=10 Participants
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
n=11 Participants
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300ug/kg
n=13 Participants
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Mucositis
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During a maximum of six 3-week chemotherapy cyclesPopulation: The number of participants for analysis was the safety population.
Number of subjects with a treatment emergent adverse event of alopecia
Outcome measures
| Measure |
Placebo
n=10 Participants
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
n=11 Participants
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300ug/kg
n=13 Participants
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Alopecia
|
1 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During a maximum of six 3-week chemotherapy cyclesPopulation: The number of participants for analysis was the safety population.
Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of: 1. Transfusions 2. Filgrastim or Pegfilgrastim 3. Erythropoietin 4. Palifermin
Outcome measures
| Measure |
Placebo
n=10 Participants
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
n=11 Participants
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300ug/kg
n=13 Participants
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Rescue Treatment for Hematopoiesis and Mucositis
Hematopoiesis - Erythropoietin
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rescue Treatment for Hematopoiesis and Mucositis
Hematopoiesis - Transfusions
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Rescue Treatment for Hematopoiesis and Mucositis
Hematopoiesis - Filgrastim or Pegfilgrastim
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Rescue Treatment for Hematopoiesis and Mucositis
Mucositis - Palifermin
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
TXA127 100 ug/kg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
TXA127 300 ug/kg
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
n=11 participants at risk
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300 ug/kg
n=13 participants at risk
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion with dyspnoea
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Abdonminal pain lower
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Female genital tract fistula
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Psychiatric disorders
Depressed mood
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
|
TXA127 100 ug/kg
n=11 participants at risk
Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
|
TXA127 300 ug/kg
n=13 participants at risk
Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Swelling face
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Urinary incontinence
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Psychiatric disorders
Crying
|
10.0%
1/10 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Psychiatric disorders
Depressed mood
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
18.2%
2/11 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Renal and urinary disorders
Dysuria
|
30.0%
3/10 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
18.2%
2/11 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Renal and urinary disorders
Enterovesical fistula
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
2/10 • Number of events 8 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
36.4%
4/11 • Number of events 16 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
38.5%
5/13 • Number of events 10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.0%
3/10 • Number of events 13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
27.3%
3/11 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.0%
1/10 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Blood and lymphatic system disorders
Neutropenia
|
70.0%
7/10 • Number of events 21 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
45.5%
5/11 • Number of events 13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
61.5%
8/13 • Number of events 18 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
5/10 • Number of events 10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
45.5%
5/11 • Number of events 15 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Blood and lymphatic system disorders
White blood cell disorder
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Cardiac disorders
Ascites
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Cardiac disorders
Chest discomfort
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Cardiac disorders
Dizziness
|
30.0%
3/10 • Number of events 5 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
27.3%
3/11 • Number of events 10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
23.1%
3/13 • Number of events 11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Ear and labyrinth disorders
Ear pruritus
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Eye disorders
Blepharospasm
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
30.8%
4/13 • Number of events 7 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
5/10 • Number of events 9 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
36.4%
4/11 • Number of events 4 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Number of events 4 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Ageusia
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Constipation
|
80.0%
8/10 • Number of events 10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
63.6%
7/11 • Number of events 12 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
38.5%
5/13 • Number of events 9 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
2/10 • Number of events 4 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
23.1%
3/13 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Dry throat
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Dyspepsia
|
30.0%
3/10 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
36.4%
4/11 • Number of events 4 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Female genital tract fistula
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Hiccups
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Nausea
|
70.0%
7/10 • Number of events 18 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
63.6%
7/11 • Number of events 17 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
69.2%
9/13 • Number of events 16 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
18.2%
2/11 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
40.0%
4/10 • Number of events 4 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Pharyngitis
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
2/10 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Tooth abscess
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Toothache
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
6/10 • Number of events 7 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
36.4%
4/11 • Number of events 9 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
38.5%
5/13 • Number of events 6 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Adverse drug reaction
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Asthenia
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 5 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Catheter site erythema
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Chest discomfort
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Chest pain
|
10.0%
1/10 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Chills
|
10.0%
1/10 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Device leakage
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Device malfunction
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Device related infection
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Discomfort
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Fatigue
|
80.0%
8/10 • Number of events 12 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
54.5%
6/11 • Number of events 17 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
53.8%
7/13 • Number of events 23 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Feeling cold
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
23.1%
3/13 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Feeling hot
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Flushing
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Hot flush
|
20.0%
2/10 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Incision site pain
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Induration
|
10.0%
1/10 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Injection site mass
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Injection site pain
|
20.0%
2/10 • Number of events 6 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
18.2%
2/11 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Injection site rash
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Injection site discomfort
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Injection site haematoma
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Injection site haemorrhage
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Lethargy
|
20.0%
2/10 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Malaise
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Night sweats
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Renal and urinary disorders
Urinary tract infection
|
10.0%
1/10 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Nodule
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
18.2%
2/11 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 8 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
18.2%
2/11 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
23.1%
3/13 • Number of events 14 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Postoperative fever
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Pyrexia
|
20.0%
2/10 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
27.3%
3/11 • Number of events 8 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
General disorders
Swelling
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Immune system disorders
Hypersensitivity
|
50.0%
5/10 • Number of events 6 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 4 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Immune system disorders
Infusion related reaction
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Immune system disorders
Seasonal allergy
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Infections and infestations
Infection
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 4 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 16 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Investigations
Blood glucose increased
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Investigations
Blood urine present
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Investigations
Transaminases abnormal
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Investigations
Weight decreased
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Investigations
Weight increased
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
27.3%
3/11 • Number of events 5 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Metabolism and nutrition disorders
Thirst
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.0%
3/10 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
45.5%
5/11 • Number of events 7 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
38.5%
5/13 • Number of events 8 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Musculoskeletal and connective tissue disorders
Chills
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Musculoskeletal and connective tissue disorders
Facial asymmetry
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Renal and urinary disorders
Urogenital fistula
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Dysphonia
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Headache
|
70.0%
7/10 • Number of events 12 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
45.5%
5/11 • Number of events 8 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
38.5%
5/13 • Number of events 16 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Hypoaesthesia
|
20.0%
2/10 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
23.1%
3/13 • Number of events 5 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Paraesthesia
|
20.0%
2/10 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
23.1%
3/13 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Tinnitus
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
18.2%
2/11 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Nervous system disorders
Tremors
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 4 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Reproductive system and breast disorders
Dyspareunia
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Reproductive system and breast disorders
Vaginal disorder
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Reproductive system and breast disorders
Vaginal lesion
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • Number of events 6 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
2/10 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
38.5%
5/13 • Number of events 16 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Musculoskeletal chest pain
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
15.4%
2/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
18.2%
2/11 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
23.1%
3/13 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Hair disorder
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
23.1%
3/13 • Number of events 5 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
38.5%
5/13 • Number of events 12 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 2 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Skin sensitisation
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Skin and subcutaneous tissue disorders
Skin warm
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Vascular disorders
Epistaxis
|
30.0%
3/10 • Number of events 4 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 3 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
9.1%
1/11 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
7.7%
1/13 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
|
Vascular disorders
Injection site haemorrhage
|
10.0%
1/10 • Number of events 1 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/11 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
0.00%
0/13 • February 2009 to May 2011
The assessment types were coded using MedDRA.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60