Trial Outcomes & Findings for Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children (NCT NCT00076999)
NCT ID: NCT00076999
Last Updated: 2014-05-12
Results Overview
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
115 participants
Primary outcome timeframe
up to 288 weeks
Results posted on
2014-05-12
Participant Flow
Participant milestones
| Measure |
TPV OS 2-<6 Yrs
Tipranavir Oral Solution (TPV OS), ages 2-5
|
TPV OS 6-<12 Yrs
Tipranavir Oral Solution (TPV OS), ages 6-11
|
TPV OS 12-18 Yrs
Tipranavir Oral Solution (TPV OS), ages 12-18
|
TPV SEDDS 6-<12 Yrs
TPV self-emulsifying drug delivery system (SEDDS), ages 6-11
|
TPV SEDDS 12-18 Yrs
TPV self-emulsifying drug delivery system (SEDDS), ages 12-18
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
31
|
19
|
6
|
34
|
|
Overall Study
COMPLETED
|
13
|
7
|
2
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
12
|
24
|
17
|
1
|
25
|
Reasons for withdrawal
| Measure |
TPV OS 2-<6 Yrs
Tipranavir Oral Solution (TPV OS), ages 2-5
|
TPV OS 6-<12 Yrs
Tipranavir Oral Solution (TPV OS), ages 6-11
|
TPV OS 12-18 Yrs
Tipranavir Oral Solution (TPV OS), ages 12-18
|
TPV SEDDS 6-<12 Yrs
TPV self-emulsifying drug delivery system (SEDDS), ages 6-11
|
TPV SEDDS 12-18 Yrs
TPV self-emulsifying drug delivery system (SEDDS), ages 12-18
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
8
|
6
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
3
|
4
|
0
|
9
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
3
|
0
|
1
|
|
Overall Study
Other reason (not specified)
|
8
|
8
|
4
|
1
|
13
|
Baseline Characteristics
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
Baseline characteristics by cohort
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
4.1 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
9.5 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
14.4 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
15.1 years
STANDARD_DEVIATION 1.7 • n=4 Participants
|
10.8 years
STANDARD_DEVIATION 4.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic / Latino
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
11 participants
n=5 Participants
|
8 participants
n=4 Participants
|
61 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 participants
n=5 Participants
|
17 participants
n=7 Participants
|
11 participants
n=5 Participants
|
19 participants
n=4 Participants
|
49 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
18 participants
n=5 Participants
|
26 participants
n=7 Participants
|
16 participants
n=5 Participants
|
20 participants
n=4 Participants
|
80 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
8 participants
n=5 Participants
|
9 participants
n=4 Participants
|
33 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
North America
|
3 participants
n=5 Participants
|
14 participants
n=7 Participants
|
13 participants
n=5 Participants
|
11 participants
n=4 Participants
|
41 participants
n=21 Participants
|
|
Region of Enrollment
South America and Mexico
|
22 participants
n=5 Participants
|
14 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
45 participants
n=21 Participants
|
|
Region of Enrollment
Europe
|
0 participants
n=5 Participants
|
9 participants
n=7 Participants
|
7 participants
n=5 Participants
|
13 participants
n=4 Participants
|
29 participants
n=21 Participants
|
|
Antiretroviral Experienced
Yes
|
24 participants
n=5 Participants
|
36 participants
n=7 Participants
|
24 participants
n=5 Participants
|
28 participants
n=4 Participants
|
112 participants
n=21 Participants
|
|
Antiretroviral Experienced
No
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 288 weeksPopulation: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=31 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=19 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=6 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=34 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Total with any severe drug-related adverse events
|
2 participants
|
6 participants
|
3 participants
|
2 participants
|
5 participants
|
|
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Alanine aminotransferase increased
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
4 participants
|
|
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Gamma-glutamyl transferase increased
|
1 participants
|
2 participants
|
2 participants
|
2 participants
|
1 participants
|
|
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Liver function test abnormal
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Hepatic enzyme abnormal
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Anemia
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Nausea
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
Hyperamylasemia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: up to 288 weeksPopulation: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=30 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=17 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=6 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=34 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Hemoglobin
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Cholesterol increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Alanine aminotransferase increased
|
0 participants
|
2 participants
|
0 participants
|
3 participants
|
6 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Amylase increased
|
2 participants
|
4 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Urine blood
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
4 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Urine protein
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Glucose increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Triglyceride increased
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Calcium decreased
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Neutrophil count decreased
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Prothombin time prolonged
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Partial thromboplastin time prolonged
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Sodium decreased
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Potassium increased
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Potassium decreased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Calcium increased
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Aspartate aminotransferase increased
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Platelets
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Creatinine phosphokinase increased
|
4 participants
|
1 participants
|
3 participants
|
0 participants
|
10 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Gamma-glutamyl transferase increased
|
4 participants
|
4 participants
|
2 participants
|
2 participants
|
3 participants
|
|
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
Sodium increased
|
2 participants
|
3 participants
|
0 participants
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)
Viral load reduction
|
20 participants
|
18 participants
|
9 participants
|
13 participants
|
—
|
|
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)
No viral load reduction
|
5 participants
|
19 participants
|
15 participants
|
16 participants
|
—
|
SECONDARY outcome
Timeframe: baseline, week 48Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)
Viral load reduction
|
19 participants
|
14 participants
|
8 participants
|
9 participants
|
—
|
|
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)
No viral load reduction
|
6 participants
|
23 participants
|
16 participants
|
20 participants
|
—
|
SECONDARY outcome
Timeframe: baseline, week 100Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)
Viral load reduction
|
14 participants
|
13 participants
|
6 participants
|
7 participants
|
—
|
|
Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)
No viral load reduction
|
11 participants
|
24 participants
|
18 participants
|
22 participants
|
—
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)
Viral load reduction
|
16 participants
|
15 participants
|
8 participants
|
10 participants
|
—
|
|
Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)
No viral load reduction
|
9 participants
|
22 participants
|
16 participants
|
19 participants
|
—
|
SECONDARY outcome
Timeframe: baseline, week 48Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)
Viral load reduction
|
18 participants
|
13 participants
|
8 participants
|
9 participants
|
—
|
|
Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)
No viral load reduction
|
7 participants
|
24 participants
|
16 participants
|
20 participants
|
—
|
SECONDARY outcome
Timeframe: baseline, week 100Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)
Viral load reduction
|
14 participants
|
11 participants
|
6 participants
|
7 participants
|
—
|
|
Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)
No viral load reduction
|
11 participants
|
26 participants
|
18 participants
|
22 participants
|
—
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)
Viral load reduction
|
10 participants
|
12 participants
|
6 participants
|
8 participants
|
—
|
|
Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)
No viral load reduction
|
15 participants
|
25 participants
|
18 participants
|
21 participants
|
—
|
SECONDARY outcome
Timeframe: baseline, week 48Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)
Viral load reduction
|
13 participants
|
13 participants
|
6 participants
|
8 participants
|
—
|
|
Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)
No viral load reduction
|
12 participants
|
24 participants
|
18 participants
|
21 participants
|
—
|
SECONDARY outcome
Timeframe: baseline, week 100Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)
Viral load reduction
|
12 participants
|
11 participants
|
5 participants
|
6 participants
|
—
|
|
Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)
No viral load reduction
|
13 participants
|
26 participants
|
19 participants
|
23 participants
|
—
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Baseline Median Viral Load log10 Copies/mL
|
5.0 log10 copies/mL
Inter-Quartile Range 4.5, 5.3 • Interval 4.5 to 5.3
|
4.6 log10 copies/mL
Inter-Quartile Range 4.4, 5.1 • Interval 4.4 to 5.1
|
5.1 log10 copies/mL
Inter-Quartile Range 4.0, 5.5 • Interval 4.0 to 5.5
|
4.6 log10 copies/mL
Interval 4.1 to 5.0
|
—
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)
|
-2.5 log10 copies/mL
Inter-Quartile Range -3.0, -1.8 • Interval -3.0 to -1.8
|
-1.7 log10 copies/mL
Inter-Quartile Range -2.7. -0.4 • Interval -2.7 to -0.4
|
-0.4 log10 copies/mL
Inter-Quartile Range -1.7, 0.0 • Interval -1.7 to 0.0
|
-1.1 log10 copies/mL
Interval -2.3 to 0.0
|
—
|
SECONDARY outcome
Timeframe: baseline, week 48Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)
|
-2.7 log10 copies/mL
Inter-Quartile Range -3.3, -1.5 • Interval -3.3 to -1.5
|
-1.0 log10 copies/mL
Inter-Quartile Range -2.4, -0.1 • Interval -2.4 to -0.1
|
-0.4 log10 copies/mL
Inter-Quartile Range -1.6, 0.0 • Interval -1.6 to 0.0
|
-0.8 log10 copies/mL
Interval -2.2 to 0.2
|
—
|
SECONDARY outcome
Timeframe: baseline, week 100Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=37 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)
|
-2.7 log10 copies/mL
Inter-Quartile Range -3.3, -1.0 • Interval -3.3 to -1.0
|
-1.2 log10 copies/mL
Inter-Quartile Range -2.4, -0.1 • Interval -2.4 to -0.1
|
-0.2 log10 copies/mL
Inter-Quartile Range -1.5, 0.0 • Interval -1.5 to 0.0
|
-0.4 log10 copies/mL
Interval -1.9 to 0.2
|
—
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=35 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Baseline Median CD4+ Cell Count (Cells/mm3)
|
795 cells/mm3
Inter-Quartile Range 536,1229 • Interval 536.0 to 1229.0
|
398 cells/mm3
Inter-Quartile Range 232,734 • Interval 232.0 to 734.0
|
208 cells/mm3
Inter-Quartile Range 100,475 • Interval 100.0 to 475.0
|
330 cells/mm3
Interval 180.0 to 389.0
|
—
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=35 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)
|
293 cells/mm3
Inter-Quartile Range 27,396 • Interval 27.0 to 396.0
|
133 cells/mm3
Inter-Quartile Range 5,217 • Interval 5.0 to 215.0
|
24 cells/mm3
Inter-Quartile Range 0, 56 • Interval 0.0 to 56.0
|
56 cells/mm3
Interval 0.0 to 168.0
|
—
|
SECONDARY outcome
Timeframe: baseline, week 48Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=35 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)
|
323 cells/mm3
Inter-Quartile Range -110,529 • Interval -110.0 to 529.0
|
143 cells/mm3
Inter-Quartile Range -6,249 • Interval -6.0 to 249.0
|
21 cells/mm3
Inter-Quartile Range 0, 95 • Interval 0.0 to 95.0
|
39 cells/mm3
Interval -61.0 to 153.0
|
—
|
SECONDARY outcome
Timeframe: baseline, week 100Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=35 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)
|
294 cells/mm3
Inter-Quartile Range -125,416 • Interval -125.0 to 416.0
|
121 cells/mm3
Inter-Quartile Range -9,319 • Interval -8.0 to 319.0
|
12 cells/mm3
Inter-Quartile Range -1,100 • Interval -1.0 to 100.0
|
45 cells/mm3
Interval 0.0 to 124.0
|
—
|
SECONDARY outcome
Timeframe: baselinePopulation: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Percentage of lymphocytes that are CD4 cells
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=35 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Median Baseline CD4 Percent
|
26 percentage of cells
Inter-Quartile Range 19, 35 • Interval 19.0 to 35.0
|
19 percentage of cells
Inter-Quartile Range 10, 29 • Interval 10.0 to 29.0
|
12 percentage of cells
Inter-Quartile Range 8, 21 • Interval 8.0 to 21.0
|
19 percentage of cells
Interval 14.0 to 25.0
|
—
|
SECONDARY outcome
Timeframe: baseline, week 24Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Percentage of lymphocytes that are CD4 cells
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=35 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)
|
7 percentage of cells
Inter-Quartile Range 2, 10 • Interval 2.0 to 10.0
|
4 percentage of cells
Inter-Quartile Range 0.8 • Interval 0.0 to 8.0
|
1 percentage of cells
Inter-Quartile Range 0.4 • Interval 0.0 to 4.0
|
2 percentage of cells
Interval 0.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: baseline, week 48Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Percentage of lymphocytes that are CD4 cells
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=35 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward)
|
7 percentage of cells
Inter-Quartile Range 2, 13 • Interval 2.0 to 13.0
|
5 percentage of cells
Inter-Quartile Range 0.8 • Interval 0.0 to 8.0
|
1 percentage of cells
Inter-Quartile Range 0.5 • Interval 0.0 to 5.0
|
3 percentage of cells
Interval -1.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: baseline, week 100Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Percentage of lymphocytes that are CD4 cells
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=35 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=23 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=29 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward)
|
6 percentage of cells
Inter-Quartile Range 3, 10 • Interval 3.0 to 10.0
|
4 percentage of cells
Inter-Quartile Range 0.9 • Interval 0.0 to 9.0
|
1 percentage of cells
Inter-Quartile Range 0.7 • Interval 0.0 to 7.0
|
0 percentage of cells
Interval -2.0 to 7.0
|
—
|
SECONDARY outcome
Timeframe: week 8Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=34 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=21 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=28 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8
Compliance
|
16 participants
|
21 participants
|
13 participants
|
10 participants
|
—
|
|
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8
Non-compliance
|
8 participants
|
13 participants
|
8 participants
|
18 participants
|
—
|
SECONDARY outcome
Timeframe: week 16Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=34 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=19 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=26 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16
Compliance
|
16 participants
|
20 participants
|
10 participants
|
13 participants
|
—
|
|
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16
Non-compliance
|
9 participants
|
14 participants
|
9 participants
|
13 participants
|
—
|
SECONDARY outcome
Timeframe: week 24Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=25 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=34 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=16 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=25 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24
Compliance
|
17 participants
|
17 participants
|
6 participants
|
14 participants
|
—
|
|
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24
Non-compliance
|
8 participants
|
17 participants
|
10 participants
|
11 participants
|
—
|
SECONDARY outcome
Timeframe: week 48Population: Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment
Outcome measures
| Measure |
TPV OS 2-<6 Yrs
n=24 Participants
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=29 Participants
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=13 Participants
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 12-18 Yrs
n=22 Participants
Patients treated with Tipranavir SEDDS, ages 12-18
|
TPV SEDDS 12-18 Yrs
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48
Compliance
|
19 participants
|
11 participants
|
5 participants
|
11 participants
|
—
|
|
Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48
Non-compliance
|
5 participants
|
18 participants
|
8 participants
|
11 participants
|
—
|
Adverse Events
TPV OS 2-<6 Yrs
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
TPV OS 6-<12 Yrs
Serious events: 13 serious events
Other events: 18 other events
Deaths: 0 deaths
TPV OS 12-18 Yrs
Serious events: 8 serious events
Other events: 10 other events
Deaths: 0 deaths
TPV SEDDS 6-<12 Yrs
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
TPV SEDDS 12-18 Yrs
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TPV OS 2-<6 Yrs
n=25 participants at risk
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=31 participants at risk
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=19 participants at risk
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 6-<12 Yrs
n=6 participants at risk
Patients treated with Tipranavir SEDDS, ages 6-11
|
TPV SEDDS 12-18 Yrs
n=34 participants at risk
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Blood and lymphatic system disorders
Aplasia pure red cell
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
General disorders
Pyrexia
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Appendicitis
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Epstein-Barr virus infection
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Erythema infectiosum
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Gastroenteritis
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Gastroenteritis rotavirus
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Gastrointestinal infection
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Groin abscess
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Herpes zoster
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Pneumonia
|
12.0%
3/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Pneumonia bacterial
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Pneumonia viral
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Postoperative wound infection
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Sinusitis
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Varicella
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Investigations
Blood potassium decreased
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Investigations
Investigation
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Investigations
Liver function test abnormal
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Investigations
Psychiatric investigation
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Nervous system disorders
Convulsion
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Nervous system disorders
Syncope
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Eye disorders
Visual impairment
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Oesophageal disorder
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Oesophageal infection
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Psychiatric disorders
Psychosomatic disease
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
Other adverse events
| Measure |
TPV OS 2-<6 Yrs
n=25 participants at risk
Patients treated with Tipranavir Oral Solution, ages 2-5
|
TPV OS 6-<12 Yrs
n=31 participants at risk
Patients treated with Tipranavir Oral Solution, ages 6-11
|
TPV OS 12-18 Yrs
n=19 participants at risk
Patients treated with Tipranavir Oral Solution, ages 12-18
|
TPV SEDDS 6-<12 Yrs
n=6 participants at risk
Patients treated with Tipranavir SEDDS, ages 6-11
|
TPV SEDDS 12-18 Yrs
n=34 participants at risk
Patients treated with Tipranavir SEDDS, ages 12-18
|
|---|---|---|---|---|---|
|
Eye disorders
Eye pruritus
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
15.8%
3/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
11.8%
4/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
16.1%
5/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
9.7%
3/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Ear and labyrinth disorders
Ear pain
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
9.7%
3/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Eye disorders
Conjunctivitis
|
20.0%
5/25 • Entire study (18Feb2004 to 30Jun2010)
|
9.7%
3/31 • Entire study (18Feb2004 to 30Jun2010)
|
15.8%
3/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Diarrhoea
|
48.0%
12/25 • Entire study (18Feb2004 to 30Jun2010)
|
35.5%
11/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
32.4%
11/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Gingivitis
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Malocclusion
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Mouth ulceration
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
9.7%
3/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Nausea
|
12.0%
3/25 • Entire study (18Feb2004 to 30Jun2010)
|
12.9%
4/31 • Entire study (18Feb2004 to 30Jun2010)
|
21.1%
4/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
29.4%
10/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
12.0%
3/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Gastrointestinal disorders
Vomiting
|
56.0%
14/25 • Entire study (18Feb2004 to 30Jun2010)
|
35.5%
11/31 • Entire study (18Feb2004 to 30Jun2010)
|
26.3%
5/19 • Entire study (18Feb2004 to 30Jun2010)
|
33.3%
2/6 • Entire study (18Feb2004 to 30Jun2010)
|
44.1%
15/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
General disorders
Asthenia
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
General disorders
Fatigue
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
General disorders
Gait disturbance
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
General disorders
Influenza like illness
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
General disorders
Injection site reaction
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
General disorders
Pyrexia
|
36.0%
9/25 • Entire study (18Feb2004 to 30Jun2010)
|
25.8%
8/31 • Entire study (18Feb2004 to 30Jun2010)
|
31.6%
6/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
26.5%
9/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Acarodermatitis
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Adenovirus infection
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Body tinea
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Cellulitis
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Cryptosporidiosis infection
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Ear infection
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
19.4%
6/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Folliculitis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Gastroenteritis
|
20.0%
5/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
HIV infection
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Impetigo
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Influenza
|
12.0%
3/25 • Entire study (18Feb2004 to 30Jun2010)
|
9.7%
3/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Nasopharyngitis
|
24.0%
6/25 • Entire study (18Feb2004 to 30Jun2010)
|
16.1%
5/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
23.5%
8/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
9.7%
3/31 • Entire study (18Feb2004 to 30Jun2010)
|
15.8%
3/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
14.7%
5/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Oral herpes
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
12.9%
4/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
14.7%
5/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Otitis externa
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
9.7%
3/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Otitis media
|
24.0%
6/25 • Entire study (18Feb2004 to 30Jun2010)
|
12.9%
4/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Otitis media acute
|
16.0%
4/25 • Entire study (18Feb2004 to 30Jun2010)
|
9.7%
3/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Parotitis
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Pharyngitis
|
20.0%
5/25 • Entire study (18Feb2004 to 30Jun2010)
|
16.1%
5/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Pneumonia
|
20.0%
5/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Rhinitis
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
9.7%
3/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
11.8%
4/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Sinusitis
|
36.0%
9/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Skin candida
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Tinea pedis
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Tonsillitis
|
20.0%
5/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Upper respiratory tract infection
|
36.0%
9/25 • Entire study (18Feb2004 to 30Jun2010)
|
22.6%
7/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
33.3%
2/6 • Entire study (18Feb2004 to 30Jun2010)
|
17.6%
6/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Varicella
|
12.0%
3/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
16.1%
5/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
33.3%
2/6 • Entire study (18Feb2004 to 30Jun2010)
|
17.6%
6/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
15.8%
3/19 • Entire study (18Feb2004 to 30Jun2010)
|
33.3%
2/6 • Entire study (18Feb2004 to 30Jun2010)
|
11.8%
4/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Investigations
Weight decreased
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
14.7%
5/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Musculoskeletal and connective tissue disorders
Epiphyses delayed fusion
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
12.9%
4/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Nervous system disorders
Convulsion
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
11.8%
4/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
22.6%
7/31 • Entire study (18Feb2004 to 30Jun2010)
|
21.1%
4/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
11.8%
4/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Nervous system disorders
Syncope
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Renal and urinary disorders
Dysuria
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Renal and urinary disorders
Enuresis
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
10/25 • Entire study (18Feb2004 to 30Jun2010)
|
41.9%
13/31 • Entire study (18Feb2004 to 30Jun2010)
|
15.8%
3/19 • Entire study (18Feb2004 to 30Jun2010)
|
50.0%
3/6 • Entire study (18Feb2004 to 30Jun2010)
|
38.2%
13/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
9.7%
3/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
2.9%
1/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
16.1%
5/31 • Entire study (18Feb2004 to 30Jun2010)
|
21.1%
4/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
12.9%
4/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
14.7%
5/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
12.9%
4/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
16.7%
1/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
2/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
5.3%
1/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
6.5%
2/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
10.5%
2/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
8.8%
3/34 • Entire study (18Feb2004 to 30Jun2010)
|
|
Vascular disorders
Haematoma
|
4.0%
1/25 • Entire study (18Feb2004 to 30Jun2010)
|
3.2%
1/31 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/19 • Entire study (18Feb2004 to 30Jun2010)
|
0.00%
0/6 • Entire study (18Feb2004 to 30Jun2010)
|
5.9%
2/34 • Entire study (18Feb2004 to 30Jun2010)
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER