Trial Outcomes & Findings for TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB). (NCT NCT00449644)
NCT ID: NCT00449644
Last Updated: 2014-04-29
Results Overview
The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
208 participants
Primary outcome timeframe
Week 8, Stage 1
Results posted on
2014-04-29
Participant Flow
This trial consisted of an exploratory stage (Stage 1) and a proof-of-efficacy stage (Stage 2). Different participants were enrolled in each stage. Participants in Stage 2 who met protocol-specified criteria were offered open-label treatment with TMC207 after Week 24 (ie, rollover arm).
A total of 208 participants were randomized and 207 (47 participants in Stage 1 and 160 participants in Stage 2) started treatment with placebo or TMC207 (1 participant did not receive study drug). One placebo participant in Stage 2 rolled-over to treatment with TMC207 after Week 24.
Participant milestones
| Measure |
TMC207 / BR (Stage 1)
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
Placebo / BR (Stage 1)
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
TMC207 / BR (Stage 2)
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
|
Placebo / BR (Stage 2)
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
79
|
81
|
|
Overall Study
Rollover
|
0
|
0
|
0
|
1
|
|
Overall Study
COMPLETED
|
13
|
11
|
50
|
49
|
|
Overall Study
NOT COMPLETED
|
10
|
13
|
29
|
32
|
Reasons for withdrawal
| Measure |
TMC207 / BR (Stage 1)
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
Placebo / BR (Stage 1)
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
TMC207 / BR (Stage 2)
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
|
Placebo / BR (Stage 2)
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
3
|
5
|
|
Overall Study
Death
|
1
|
0
|
6
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
5
|
3
|
|
Overall Study
Pregnancy
|
0
|
0
|
3
|
2
|
|
Overall Study
Protocol Violation
|
4
|
4
|
3
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
6
|
7
|
|
Overall Study
Inclusion/exclusion criteria not met
|
0
|
0
|
2
|
6
|
|
Overall Study
Other
|
1
|
4
|
1
|
0
|
|
Overall Study
Rolled-over to treatment with TMC207
|
0
|
0
|
0
|
1
|
Baseline Characteristics
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
Baseline characteristics by cohort
| Measure |
TMC207 / BR (Stage 1)
n=23 Participants
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
Placebo / BR (Stage 1)
n=24 Participants
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
TMC207 / BR (Stage 2)
n=79 Participants
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
|
Placebo / BR (Stage 2)
n=81 Participants
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
33.6 years
STANDARD_DEVIATION 11.04 • n=7 Participants
|
36.2 years
STANDARD_DEVIATION 13.13 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 11.01 • n=4 Participants
|
35.7 years
STANDARD_DEVIATION 11.88 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 8, Stage 1Population: The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.
The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.
Outcome measures
| Measure |
TMC207 / BR (Stage 1)
n=21 Participants
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
|
Placebo / BR (Stage 1)
n=23 Participants
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
|---|---|---|
|
The Time to Sputum Culture Conversion at Week 8 (Stage 1)
|
51 Days
Interval 30.0 to
The curve of the upper limit around the time to response curve does not cross 50%.
|
NA Days
The Kaplan-Meier curve of time to response does not cross the 50% line for Placebo.
|
PRIMARY outcome
Timeframe: Week 24, Stage 2Population: The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.
The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.
Outcome measures
| Measure |
TMC207 / BR (Stage 1)
n=66 Participants
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
|
Placebo / BR (Stage 1)
n=66 Participants
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
|---|---|---|
|
The Time to Sputum Culture Conversion at Week 24 (Stage 2)
|
83 Days
Interval 56.0 to 97.0
|
125 Days
Interval 98.0 to 168.0
|
SECONDARY outcome
Timeframe: Week 24, Stage 1Population: The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.
The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.
Outcome measures
| Measure |
TMC207 / BR (Stage 1)
n=21 Participants
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
|
Placebo / BR (Stage 1)
n=23 Participants
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
|---|---|---|
|
The Time to Sputum Culture Conversion at Week 24 (Stage 1)
|
70 Days
Interval 49.0 to 100.0
|
126 Days
Interval 98.0 to 134.0
|
SECONDARY outcome
Timeframe: Week 72, Stage 2Population: The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.
The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.
Outcome measures
| Measure |
TMC207 / BR (Stage 1)
n=66 Participants
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
|
Placebo / BR (Stage 1)
n=66 Participants
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
|---|---|---|
|
The Time to Sputum Culture Conversion at Week 72 (Stage 2)
|
86 Days
Interval 70.0 to 99.0
|
168 Days
Interval 112.0 to 345.0
|
SECONDARY outcome
Timeframe: Week 8, 24, and 104 (Stage 1)Population: The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.
The table below shows the percentage of participants in Stage 1 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders.
Outcome measures
| Measure |
TMC207 / BR (Stage 1)
n=21 Participants
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
|
Placebo / BR (Stage 1)
n=23 Participants
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
|---|---|---|
|
The Percentage of Participants With Sputum Culture Conversion (Stage 1)
Week 8
|
47.6 Percentage of Participants
|
8.7 Percentage of Participants
|
|
The Percentage of Participants With Sputum Culture Conversion (Stage 1)
Week 24
|
81.0 Percentage of Participants
|
65.2 Percentage of Participants
|
|
The Percentage of Participants With Sputum Culture Conversion (Stage 1)
Week 104 (Stage 1 Trial End)
|
52.4 Percentage of Participants
|
43.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 24, Week 72, and Week 120 (Stage 2)Population: The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.
The table below shows the percentage of participants in Stage 2 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders.
Outcome measures
| Measure |
TMC207 / BR (Stage 1)
n=66 Participants
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
|
Placebo / BR (Stage 1)
n=66 Participants
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
|---|---|---|
|
The Percentage of Participants With Sputum Culture Conversion (Stage 2)
Week 72
|
71.2 Percentage of Participants
|
56.1 Percentage of Participants
|
|
The Percentage of Participants With Sputum Culture Conversion (Stage 2)
Week 120
|
62.1 Percentage of Participants
|
43.9 Percentage of Participants
|
|
The Percentage of Participants With Sputum Culture Conversion (Stage 2)
Week 24
|
78.8 Percentage of Participants
|
57.6 Percentage of Participants
|
Adverse Events
TMC207 / BR (Stage 1)
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo / BR (Stage 1)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
TMC207 / BR (Stage 2)
Serious events: 18 serious events
Other events: 75 other events
Deaths: 0 deaths
Placebo / BR (Stage 2)
Serious events: 15 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TMC207 / BR (Stage 1)
n=23 participants at risk
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
Placebo / BR (Stage 1)
n=24 participants at risk
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
TMC207 / BR (Stage 2)
n=79 participants at risk
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
|
Placebo / BR (Stage 2)
n=81 participants at risk
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Ear and labyrinth disorders
Conductive deafness
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.2%
1/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
2.5%
2/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
2.5%
2/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.2%
1/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Pyothorax
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
2.5%
2/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
3.7%
3/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.2%
1/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.2%
1/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
4.3%
1/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.2%
1/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
2.5%
2/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.2%
1/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.2%
1/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.2%
1/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.9%
4/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
Other adverse events
| Measure |
TMC207 / BR (Stage 1)
n=23 participants at risk
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
Placebo / BR (Stage 1)
n=24 participants at risk
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
|
TMC207 / BR (Stage 2)
n=79 participants at risk
Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
|
Placebo / BR (Stage 2)
n=81 participants at risk
Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
7.6%
6/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
3.7%
3/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Ear and labyrinth disorders
Deafness
|
4.3%
1/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
6.3%
5/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.9%
4/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
13.0%
3/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
12.5%
3/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
6.3%
5/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.6%
7/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
13.0%
3/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
20.8%
5/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
12.7%
10/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.6%
7/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
5.1%
4/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
3.7%
3/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
3.8%
3/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
13.6%
11/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
6.3%
5/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
2.5%
2/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.3%
2/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
7.6%
6/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
7.4%
6/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
1/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
12.7%
10/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
9.9%
8/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
5.1%
4/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.0%
3/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
6.3%
5/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
18.5%
15/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
5.1%
4/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
14.8%
12/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
11.4%
9/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
19.8%
16/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
26.1%
6/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
40.5%
32/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
37.0%
30/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
12.5%
3/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
29.1%
23/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
27.2%
22/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
General disorders
Chest pain
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.3%
2/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
12.7%
10/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
9.9%
8/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
General disorders
Fatigue
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
7.6%
6/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.2%
1/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
General disorders
Injection site pain
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
11.4%
9/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
12.3%
10/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
General disorders
Non-cardiac chest pain
|
8.7%
2/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.3%
2/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
2.5%
2/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
General disorders
Pain
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
2.5%
2/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
7.4%
6/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
General disorders
Pyrexia
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
10.1%
8/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.6%
7/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Influenza
|
4.3%
1/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
7.6%
6/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
11.1%
9/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
13.9%
11/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.9%
4/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
7.6%
6/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
6.2%
5/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
6.3%
5/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
2.5%
2/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
5.1%
4/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.2%
1/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
6.3%
5/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
2.5%
2/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Investigations
Blood uric acid increased
|
4.3%
1/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.3%
2/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
6.3%
5/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
3.7%
3/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Investigations
Transaminases increased
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
6.3%
5/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Investigations
Weight decreased
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
3.8%
3/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
6.2%
5/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
11.4%
9/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
7.4%
6/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
17.4%
4/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
12.5%
3/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
25.3%
20/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
33.3%
27/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
5.1%
4/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
3.7%
3/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.4%
4/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
12.5%
3/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
36.7%
29/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
27.2%
22/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
12.5%
3/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
11.4%
9/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
9.9%
8/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.3%
1/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
5.1%
4/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.9%
4/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
7.6%
6/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.6%
7/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
2/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
16.7%
4/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
2.5%
2/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
3.7%
3/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Nervous system disorders
Dizziness
|
13.0%
3/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.3%
2/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
13.9%
11/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
13.6%
11/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.3%
2/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
29.1%
23/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
22.2%
18/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
5.1%
4/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
2.5%
2/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
5.1%
4/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.9%
4/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Psychiatric disorders
Depression
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
3.8%
3/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.6%
7/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
16.5%
13/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
12.3%
10/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.9%
7/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
9.9%
8/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.2%
1/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
3.8%
3/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
7.4%
6/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
5.1%
4/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
13.0%
3/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
16.7%
4/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
19.0%
15/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
16.0%
13/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.3%
1/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.3%
2/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
1.3%
1/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.9%
4/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
8.7%
2/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
2.5%
2/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
6.2%
5/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
5.1%
4/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.3%
1/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.3%
2/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
0.00%
0/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
2.5%
2/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.7%
2/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
8.3%
2/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
13.9%
11/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
18.5%
15/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.7%
2/23 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
16.7%
4/24 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
7.6%
6/79 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
4.9%
4/81 • Stage 1: Adverse Events were collected from 05-Jun-2007 to 04-Dec-2009. Stage 2: Adverse events were collected from 23-Apr-2008 to 31-Jan-2012.
Treatment-Emergent Adverse Events (TEAE) from overall treatment phase are reported. Only patients who had at least one of the TEAEs are listed in the Other (non Serious) Adverse Event table are included in the total number of patients with Non-Serious Adverse Events.
|
Additional Information
Medical Leader
Janssen Infectious Diseases - Diagnostics BVBA
Phone: 1 609 730-7768
Results disclosure agreements
- Principal investigator is a sponsor employee It is the policy of the sponsor not to allow the investigators to publish their results or findings prior to the sponsor's publication of the overall trial results.The investigator agrees that before he/she publishes any results of this trial, he/she shall provide the sponsor with at least 45 days for full review of the prepublication manuscript prior to submission of the manuscript to the publisher.
- Publication restrictions are in place
Restriction type: OTHER