Trial Outcomes & Findings for High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals (NCT NCT00885703)
NCT ID: NCT00885703
Last Updated: 2021-11-04
Results Overview
Discontinuation of study-provided high dose fluconazole at or by week 10 Discontinuation of study-provided ampho B at or by week 2 Discontinuation includes discontinuing for any reason, including progression of symptoms, death, etc.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
168 participants
Primary outcome timeframe
Measured from study entry through Week10
Results posted on
2021-11-04
Participant Flow
The study opened on February 19, 2010. The first participant enrolled on April 16, 2010. Stage 1 closed on September 5, 2013. A5225 Stage 2 opened on September 15, 2014 and the first participant enrolled on February 2, 2015. Stage 2 closed on August 19, 2016. Ten sites enrolled participants (1 domestic, 9 international).
Participant milestones
| Measure |
Stage 1, Fluconazole 1200mg
Participants receive Fluconazole 1200mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fulconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
26
|
24
|
24
|
24
|
24
|
24
|
|
Overall Study
COMPLETED
|
12
|
16
|
13
|
15
|
12
|
11
|
18
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
11
|
9
|
12
|
13
|
6
|
Reasons for withdrawal
| Measure |
Stage 1, Fluconazole 1200mg
Participants receive Fluconazole 1200mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fulconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
9
|
7
|
8
|
7
|
7
|
8
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
3
|
1
|
1
|
|
Overall Study
Ineligible (no CM)
|
1
|
3
|
2
|
1
|
2
|
3
|
1
|
Baseline Characteristics
One participant missing baseline Glasgow Coma Score.
Baseline characteristics by cohort
| Measure |
Stage 1, Fluconazole 1200mg
n=22 Participants
Participants receive Fluconazole 1200mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 1600mg
n=26 Participants
Participants receive Fluconazole 1600mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
n=24 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
n=24 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
n=24 Participants
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fluconazole 2000mg
n=24 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
n=24 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.5 years
n=22 Participants
|
33 years
n=26 Participants
|
38 years
n=24 Participants
|
35.5 years
n=24 Participants
|
32.5 years
n=24 Participants
|
33.5 years
n=24 Participants
|
37.5 years
n=24 Participants
|
36 years
n=168 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=22 Participants
|
14 Participants
n=26 Participants
|
14 Participants
n=24 Participants
|
11 Participants
n=24 Participants
|
10 Participants
n=24 Participants
|
10 Participants
n=24 Participants
|
9 Participants
n=24 Participants
|
78 Participants
n=168 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=22 Participants
|
12 Participants
n=26 Participants
|
10 Participants
n=24 Participants
|
13 Participants
n=24 Participants
|
14 Participants
n=24 Participants
|
14 Participants
n=24 Participants
|
15 Participants
n=24 Participants
|
90 Participants
n=168 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
12 Participants
n=22 Participants
|
21 Participants
n=26 Participants
|
22 Participants
n=24 Participants
|
19 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
22 Participants
n=24 Participants
|
23 Participants
n=24 Participants
|
143 Participants
n=168 Participants
|
|
Race/Ethnicity, Customized
Hispanic (regardless of Race)
|
0 Participants
n=22 Participants
|
4 Participants
n=26 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
10 Participants
n=168 Participants
|
|
Race/Ethnicity, Customized
Asian, Pacific Islander
|
10 Participants
n=22 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
15 Participants
n=168 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=22 Participants
|
0 participants
n=26 Participants
|
2 participants
n=24 Participants
|
1 participants
n=24 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
4 participants
n=168 Participants
|
|
Region of Enrollment
South Africa
|
1 participants
n=22 Participants
|
6 participants
n=26 Participants
|
3 participants
n=24 Participants
|
5 participants
n=24 Participants
|
2 participants
n=24 Participants
|
3 participants
n=24 Participants
|
6 participants
n=24 Participants
|
26 participants
n=168 Participants
|
|
Region of Enrollment
Uganda
|
0 participants
n=22 Participants
|
2 participants
n=26 Participants
|
11 participants
n=24 Participants
|
5 participants
n=24 Participants
|
14 participants
n=24 Participants
|
13 participants
n=24 Participants
|
12 participants
n=24 Participants
|
57 participants
n=168 Participants
|
|
Region of Enrollment
Zimbabwe
|
2 participants
n=22 Participants
|
4 participants
n=26 Participants
|
1 participants
n=24 Participants
|
3 participants
n=24 Participants
|
4 participants
n=24 Participants
|
1 participants
n=24 Participants
|
3 participants
n=24 Participants
|
18 participants
n=168 Participants
|
|
Region of Enrollment
Kenya
|
8 participants
n=22 Participants
|
9 participants
n=26 Participants
|
7 participants
n=24 Participants
|
6 participants
n=24 Participants
|
4 participants
n=24 Participants
|
6 participants
n=24 Participants
|
2 participants
n=24 Participants
|
42 participants
n=168 Participants
|
|
Region of Enrollment
Thailand
|
5 participants
n=22 Participants
|
0 participants
n=26 Participants
|
0 participants
n=24 Participants
|
1 participants
n=24 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
6 participants
n=168 Participants
|
|
Region of Enrollment
Peru
|
0 participants
n=22 Participants
|
4 participants
n=26 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
1 participants
n=24 Participants
|
1 participants
n=24 Participants
|
6 participants
n=168 Participants
|
|
Region of Enrollment
India
|
5 participants
n=22 Participants
|
1 participants
n=26 Participants
|
0 participants
n=24 Participants
|
3 participants
n=24 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
9 participants
n=168 Participants
|
|
Weight
|
46.5 kilograms
n=22 Participants
|
50.5 kilograms
n=26 Participants
|
51.9 kilograms
n=24 Participants
|
56.8 kilograms
n=24 Participants
|
49.8 kilograms
n=24 Participants
|
55.0 kilograms
n=24 Participants
|
52.5 kilograms
n=24 Participants
|
52.0 kilograms
n=168 Participants
|
|
BMI (Body Mass Index)
|
17.2 kg/m^2
n=22 Participants
|
19.6 kg/m^2
n=26 Participants
|
18.3 kg/m^2
n=24 Participants
|
19.8 kg/m^2
n=24 Participants
|
18.7 kg/m^2
n=24 Participants
|
19.8 kg/m^2
n=24 Participants
|
19.6 kg/m^2
n=24 Participants
|
18.9 kg/m^2
n=168 Participants
|
|
CD4+
< 50 cells/mm^3
|
15 Participants
n=22 Participants
|
10 Participants
n=26 Participants
|
17 Participants
n=24 Participants
|
17 Participants
n=24 Participants
|
20 Participants
n=24 Participants
|
16 Participants
n=24 Participants
|
17 Participants
n=24 Participants
|
112 Participants
n=168 Participants
|
|
CD4+
50 - <100 cells/mm^3
|
6 Participants
n=22 Participants
|
9 Participants
n=26 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=24 Participants
|
36 Participants
n=168 Participants
|
|
CD4+
100 - <200 cells/mm^3
|
1 Participants
n=22 Participants
|
4 Participants
n=26 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
15 Participants
n=168 Participants
|
|
CD4+
200+ cells/mm^3
|
0 Participants
n=22 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=168 Participants
|
|
HIV-1 RNA
|
5.3 log10(copies/mL)
n=22 Participants
|
5.6 log10(copies/mL)
n=26 Participants
|
5.5 log10(copies/mL)
n=24 Participants
|
5.4 log10(copies/mL)
n=24 Participants
|
5.2 log10(copies/mL)
n=24 Participants
|
4.9 log10(copies/mL)
n=24 Participants
|
4.6 log10(copies/mL)
n=24 Participants
|
5.3 log10(copies/mL)
n=168 Participants
|
|
Glasgow Coma Score
GCS <15
|
5 Participants
n=22 Participants • One participant missing baseline Glasgow Coma Score.
|
3 Participants
n=26 Participants • One participant missing baseline Glasgow Coma Score.
|
5 Participants
n=24 Participants • One participant missing baseline Glasgow Coma Score.
|
1 Participants
n=24 Participants • One participant missing baseline Glasgow Coma Score.
|
2 Participants
n=24 Participants • One participant missing baseline Glasgow Coma Score.
|
0 Participants
n=23 Participants • One participant missing baseline Glasgow Coma Score.
|
0 Participants
n=24 Participants • One participant missing baseline Glasgow Coma Score.
|
16 Participants
n=167 Participants • One participant missing baseline Glasgow Coma Score.
|
|
Glasgow Coma Score
GCS =15
|
17 Participants
n=22 Participants • One participant missing baseline Glasgow Coma Score.
|
23 Participants
n=26 Participants • One participant missing baseline Glasgow Coma Score.
|
19 Participants
n=24 Participants • One participant missing baseline Glasgow Coma Score.
|
23 Participants
n=24 Participants • One participant missing baseline Glasgow Coma Score.
|
22 Participants
n=24 Participants • One participant missing baseline Glasgow Coma Score.
|
23 Participants
n=23 Participants • One participant missing baseline Glasgow Coma Score.
|
24 Participants
n=24 Participants • One participant missing baseline Glasgow Coma Score.
|
151 Participants
n=167 Participants • One participant missing baseline Glasgow Coma Score.
|
|
Quantitative Cryptococcal Meningitis Culture
|
5.18 Log10 CFU/mL
n=22 Participants
|
4.45 Log10 CFU/mL
n=26 Participants
|
5.15 Log10 CFU/mL
n=24 Participants
|
4.37 Log10 CFU/mL
n=24 Participants
|
5.34 Log10 CFU/mL
n=24 Participants
|
4.29 Log10 CFU/mL
n=24 Participants
|
5.14 Log10 CFU/mL
n=24 Participants
|
5.04 Log10 CFU/mL
n=168 Participants
|
|
Anti-Retroviral Therapy (ART) Status
On ART
|
0 Participants
n=22 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
8 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
11 Participants
n=24 Participants
|
31 Participants
n=168 Participants
|
|
Anti-Retroviral Therapy (ART) Status
Not on ART
|
22 Participants
n=22 Participants
|
26 Participants
n=26 Participants
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
16 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
13 Participants
n=24 Participants
|
137 Participants
n=168 Participants
|
|
Opportunistic Infections
One or more opportunistic infections
|
10 Participants
n=22 Participants
|
7 Participants
n=26 Participants
|
11 Participants
n=24 Participants
|
10 Participants
n=24 Participants
|
11 Participants
n=24 Participants
|
9 Participants
n=24 Participants
|
10 Participants
n=24 Participants
|
68 Participants
n=168 Participants
|
|
Opportunistic Infections
No opportunistic infections
|
12 Participants
n=22 Participants
|
19 Participants
n=26 Participants
|
13 Participants
n=24 Participants
|
14 Participants
n=24 Participants
|
13 Participants
n=24 Participants
|
15 Participants
n=24 Participants
|
14 Participants
n=24 Participants
|
100 Participants
n=168 Participants
|
|
Mini Mental Status
|
26 Scores on a scale
n=19 Participants • Not all participants were able to complete a Mini Mental Status at baseline.
|
25 Scores on a scale
n=25 Participants • Not all participants were able to complete a Mini Mental Status at baseline.
|
26 Scores on a scale
n=21 Participants • Not all participants were able to complete a Mini Mental Status at baseline.
|
26 Scores on a scale
n=22 Participants • Not all participants were able to complete a Mini Mental Status at baseline.
|
26 Scores on a scale
n=23 Participants • Not all participants were able to complete a Mini Mental Status at baseline.
|
26 Scores on a scale
n=24 Participants • Not all participants were able to complete a Mini Mental Status at baseline.
|
25.5 Scores on a scale
n=24 Participants • Not all participants were able to complete a Mini Mental Status at baseline.
|
26 Scores on a scale
n=158 Participants • Not all participants were able to complete a Mini Mental Status at baseline.
|
|
Opening Pressure (from Lumbar Pucture)
|
200 mm H20
n=21 Participants • Not all participants were able to have a lumbar puncture at entry.
|
200 mm H20
n=26 Participants • Not all participants were able to have a lumbar puncture at entry.
|
350 mm H20
n=23 Participants • Not all participants were able to have a lumbar puncture at entry.
|
190 mm H20
n=23 Participants • Not all participants were able to have a lumbar puncture at entry.
|
200 mm H20
n=24 Participants • Not all participants were able to have a lumbar puncture at entry.
|
190 mm H20
n=24 Participants • Not all participants were able to have a lumbar puncture at entry.
|
303 mm H20
n=24 Participants • Not all participants were able to have a lumbar puncture at entry.
|
210 mm H20
n=165 Participants • Not all participants were able to have a lumbar puncture at entry.
|
|
White Blood Cell count (from CSF)
|
80 cells/mm^3
n=19 Participants • Not all participants were able to have a lumbar puncture. Of those that did, not all were able to have enough fluid collected for WBC count.
|
30 cells/mm^3
n=21 Participants • Not all participants were able to have a lumbar puncture. Of those that did, not all were able to have enough fluid collected for WBC count.
|
17 cells/mm^3
n=23 Participants • Not all participants were able to have a lumbar puncture. Of those that did, not all were able to have enough fluid collected for WBC count.
|
26 cells/mm^3
n=21 Participants • Not all participants were able to have a lumbar puncture. Of those that did, not all were able to have enough fluid collected for WBC count.
|
19 cells/mm^3
n=23 Participants • Not all participants were able to have a lumbar puncture. Of those that did, not all were able to have enough fluid collected for WBC count.
|
16 cells/mm^3
n=23 Participants • Not all participants were able to have a lumbar puncture. Of those that did, not all were able to have enough fluid collected for WBC count.
|
13 cells/mm^3
n=23 Participants • Not all participants were able to have a lumbar puncture. Of those that did, not all were able to have enough fluid collected for WBC count.
|
19 cells/mm^3
n=153 Participants • Not all participants were able to have a lumbar puncture. Of those that did, not all were able to have enough fluid collected for WBC count.
|
|
Albumin
|
3.0 g/dL
n=22 Participants • Not all participants had an albumin measurement.
|
3.2 g/dL
n=26 Participants • Not all participants had an albumin measurement.
|
3.3 g/dL
n=24 Participants • Not all participants had an albumin measurement.
|
3.2 g/dL
n=24 Participants • Not all participants had an albumin measurement.
|
3.1 g/dL
n=24 Participants • Not all participants had an albumin measurement.
|
3.1 g/dL
n=23 Participants • Not all participants had an albumin measurement.
|
3.1 g/dL
n=24 Participants • Not all participants had an albumin measurement.
|
3.2 g/dL
n=167 Participants • Not all participants had an albumin measurement.
|
|
ALT (Alanine Aminotransferase)
|
15.7 U/L
n=22 Participants
|
19.0 U/L
n=26 Participants
|
24.7 U/L
n=24 Participants
|
21.5 U/L
n=24 Participants
|
25.2 U/L
n=24 Participants
|
24.1 U/L
n=24 Participants
|
18.1 U/L
n=24 Participants
|
20.6 U/L
n=168 Participants
|
|
Creatinine Clearance
|
94.2 mL/min
n=22 Participants
|
94.5 mL/min
n=26 Participants
|
94.2 mL/min
n=24 Participants
|
102.3 mL/min
n=24 Participants
|
94.0 mL/min
n=24 Participants
|
98.8 mL/min
n=24 Participants
|
94.4 mL/min
n=24 Participants
|
95.0 mL/min
n=168 Participants
|
|
Cryptococcal Antigen (CrAG) Titer
|
756 titers
n=22 Participants • Not all participants had a CrAG titer observed at baseline.
|
128 titers
n=23 Participants • Not all participants had a CrAG titer observed at baseline.
|
815.5 titers
n=22 Participants • Not all participants had a CrAG titer observed at baseline.
|
1050 titers
n=23 Participants • Not all participants had a CrAG titer observed at baseline.
|
256 titers
n=23 Participants • Not all participants had a CrAG titer observed at baseline.
|
128 titers
n=23 Participants • Not all participants had a CrAG titer observed at baseline.
|
416 titers
n=22 Participants • Not all participants had a CrAG titer observed at baseline.
|
452.5 titers
n=158 Participants • Not all participants had a CrAG titer observed at baseline.
|
PRIMARY outcome
Timeframe: Measured from study entry through Week10Population: Analysis in safety population (see study detailed description for details)
Discontinuation of study-provided high dose fluconazole at or by week 10 Discontinuation of study-provided ampho B at or by week 2 Discontinuation includes discontinuing for any reason, including progression of symptoms, death, etc.
Outcome measures
| Measure |
Fluconazole 1600mg
n=26 Participants
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Fluconazole 1200mg
n=22 Participants
Participants receive Fluconazole 1200mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
n=24 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
n=24 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
n=24 Participants
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fluconazole 2000mg
n=24 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
n=24 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B
|
11 Participants
|
14 Participants
|
11 Participants
|
6 Participants
|
12 Participants
|
13 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: At entry, Week 2, and Week 10Population: Arms pooled by dose. Analysis in efficacy population (see study detailed description for details).
Count of participants who were CM negative (had no cryptococcal growth), CM negative after switching treatment (switched from Fluconazole to Ampho B or vice versa and later became CM negative), CM positive, Died, Lost to follow-up. Note: CM positive means continued to have cryptococcal growth.
Outcome measures
| Measure |
Fluconazole 1600mg
n=45 Participants
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Fluconazole 1200mg
n=20 Participants
Participants receive Fluconazole 1200mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
n=43 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
n=46 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fluconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Categorized Quantitative Culture Results
Week 0 · CM Positive
|
45 Participants
|
20 Participants
|
43 Participants
|
46 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 0 · CM Negative
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 0 · CM Negative after switching treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 0 · Died
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 0 · Lost to Follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 2 · CM Positive
|
27 Participants
|
12 Participants
|
27 Participants
|
29 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 2 · CM Negative
|
12 Participants
|
3 Participants
|
10 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 2 · CM Negative after switching treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 2 · Died
|
6 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 2 · Lost to Follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 10 · CM Positive
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 10 · CM Negative
|
24 Participants
|
8 Participants
|
22 Participants
|
37 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 10 · CM Negative after switching treatment
|
4 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 10 · Died
|
10 Participants
|
8 Participants
|
12 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Categorized Quantitative Culture Results
Week 10 · Lost to Follow-up
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Entry and Week 2Population: Arms pooled by dose. Analysis done in efficacy population (see study detailed description for details). Excludes participants who did not have a week 2 observation.
Change in quantitative CSF (cerebrospinal fluid) cultures. Note: No further CSF specimens are drawn following a negative culture. Thus, only week 2 CSF cultures are considered in this analysis.
Outcome measures
| Measure |
Fluconazole 1600mg
n=36 Participants
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Fluconazole 1200mg
n=15 Participants
Participants receive Fluconazole 1200mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
n=37 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
n=40 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fluconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Change in Log10 Quantitative CSF Culture Results
|
-2.51 Log10 CFU/mL
Interval -4.0 to -1.44
|
-1.51 Log10 CFU/mL
Interval -2.9 to -0.91
|
-1.78 Log10 CFU/mL
Interval -3.24 to -1.0
|
-2.81 Log10 CFU/mL
Interval -4.09 to -1.92
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured from study entry through Week 24Population: Arms pooled by dose in the safety population (see study detailed description for details).
Kaplan Meier Proportion of participants who died over study with 90% Confidence Intervals.
Outcome measures
| Measure |
Fluconazole 1600mg
n=50 Participants
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Fluconazole 1200mg
n=22 Participants
Participants receive Fluconazole 1200mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
n=48 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
n=48 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fluconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Kaplan Meier (KM) Proportion of Participant Mortality
|
0.30 proportion of participants
Interval 0.2 to 0.43
|
0.41 proportion of participants
Interval 0.26 to 0.6
|
0.36 proportion of participants
Interval 0.25 to 0.49
|
0.24 proportion of participants
Interval 0.15 to 0.36
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at study entry, Week 2, and Week 10Population: Arms pooled by dose. Safety population (see study detailed description for details).
Results from Glasgow Coma Score, which provides assessment of impairment of conscious level in response to defined stimuli. Min score of 0 and max score of 15 (no mental impairment).
Outcome measures
| Measure |
Fluconazole 1600mg
n=50 Participants
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Fluconazole 1200mg
n=22 Participants
Participants receive Fluconazole 1200mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
n=48 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
n=48 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fluconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Results of the Neurological Examination
Week 0 · Score < 15
|
5 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Results of the Neurological Examination
Week 0 · Score = 15
|
45 Participants
|
17 Participants
|
42 Participants
|
47 Participants
|
—
|
—
|
—
|
|
Results of the Neurological Examination
Week 2 · Score < 15
|
4 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Results of the Neurological Examination
Week 2 · Score = 15
|
38 Participants
|
15 Participants
|
36 Participants
|
38 Participants
|
—
|
—
|
—
|
|
Results of the Neurological Examination
Week 10 · Score < 15
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Results of the Neurological Examination
Week 10 · Score = 15
|
33 Participants
|
11 Participants
|
26 Participants
|
34 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured 6 weeks before enrollment, at study entry, at Week 10, and at Week 24Population: Arms pooled by dose. Safety population (see study detailed description for details).
Functional assessment of work status and ability. Consists of 2 measures: 1) Does participants have full time work status 2) Does participant have functional ability to work. The measure from 6 week before enrollment will be referred to as 'baseline'.
Outcome measures
| Measure |
Fluconazole 1600mg
n=50 Participants
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Fluconazole 1200mg
n=22 Participants
Participants receive Fluconazole 1200mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
n=48 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
n=48 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fluconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Results of Functional Status Evaluation
Baseline Had full time work status
|
41 Participants
|
18 Participants
|
36 Participants
|
42 Participants
|
—
|
—
|
—
|
|
Results of Functional Status Evaluation
Entry Had full time work status
|
9 Participants
|
3 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Results of Functional Status Evaluation
Week 10 Had full time work status
|
16 Participants
|
3 Participants
|
9 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Results of Functional Status Evaluation
Week 24 Had full time work status
|
18 Participants
|
7 Participants
|
17 Participants
|
22 Participants
|
—
|
—
|
—
|
|
Results of Functional Status Evaluation
Baseline Had functional ability to work
|
41 Participants
|
16 Participants
|
32 Participants
|
38 Participants
|
—
|
—
|
—
|
|
Results of Functional Status Evaluation
Entry Had functional ability to work
|
8 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Results of Functional Status Evaluation
Week 10 Had functional ability to work
|
18 Participants
|
4 Participants
|
9 Participants
|
15 Participants
|
—
|
—
|
—
|
|
Results of Functional Status Evaluation
Week 24 Had functional ability to work
|
19 Participants
|
7 Participants
|
16 Participants
|
24 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured from study entry through Week 10Population: Arms pooled by dose in safety population (see study detailed description for details). Fluconazole 2000mg arm had one participant data missing (was not admitted to hospital at study entry).
Duration of first hospitalization in days starting at entry in safety population.
Outcome measures
| Measure |
Fluconazole 1600mg
n=50 Participants
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Fluconazole 1200mg
n=22 Participants
Participants receive Fluconazole 1200mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
n=47 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
n=48 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fluconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Length of Hospitalization
|
17.5 Days
Interval 10.0 to 28.0
|
15 Days
Interval 10.0 to 21.0
|
18 Days
Interval 13.0 to 36.0
|
18.5 Days
Interval 17.0 to 26.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured from study entry through Week 24Population: Arms pooled by dose in safety population (see study detailed description for details).
Count of number of times a participant was admitted to the hospital.
Outcome measures
| Measure |
Fluconazole 1600mg
n=50 Participants
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Fluconazole 1200mg
n=22 Participants
Participants receive Fluconazole 1200mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
n=48 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
n=48 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fluconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Number of Hospital Admissions
1 hospital admission
|
39 Participants
|
18 Participants
|
41 Participants
|
37 Participants
|
—
|
—
|
—
|
|
Number of Hospital Admissions
2 hospital admissions
|
9 Participants
|
1 Participants
|
6 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Hospital Admissions
3 hospital admissions
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured from study entry through Week 24Population: Arms pooled by dose. Analysis done in efficacy population (see detailed study description for details).
Progression of symptoms is defined as: * Died (including early deaths) * Discontinued Fluconazole and started ampho B * Had a positive cryptococcal culture at week 10 * Microbiological Failure (i.e., relapse of CM) * Complication of CM (e.g., obstructive hydrocephalus or vascular complications such as venous or arterial thrombosis) * CM IRIS causing increased inflammation after ART exposure * New CNS Ol (e.g., toxoplasmosis, PML, CNS lymphoma) * Possibly related to CM but mechanism indeterminate * Other defined complication unrelated to CM
Outcome measures
| Measure |
Fluconazole 1600mg
n=45 Participants
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Fluconazole 1200mg
n=20 Participants
Participants receive Fluconazole 1200mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
n=43 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
n=46 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fluconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Progression of Symptoms
|
21 Participants
|
14 Participants
|
24 Participants
|
19 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured from study entry through Week 24Population: Arms pooled by dose in study population (see study detailed description for details).
Number of participants who were diagnosed with CNS immune reconstitution inflammatory syndrome (IRIS)
Outcome measures
| Measure |
Fluconazole 1600mg
n=50 Participants
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Fluconazole 1200mg
n=22 Participants
Participants receive Fluconazole 1200mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
n=48 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
n=48 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fluconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With CNS IRIS
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured from study entry through Week 24Population: Arms pooled by dose in safety population (see study detailed description for details).
Occurrence of grade 3 (severe) and 4 (life-threatening) sign and symptoms events (as defined by FSTRF Appendix 29) Occurrence of grade 3 (severe) and 4 (life-threatening) laboratory events (as defined by FSTRF Appendix 76) See DAIDS AE Grading table V1.0
Outcome measures
| Measure |
Fluconazole 1600mg
n=50 Participants
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Fluconazole 1200mg
n=22 Participants
Participants receive Fluconazole 1200mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Fluconazole 2000mg
n=48 Participants
Participants receive Fluconazole 2000mg induction dose in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1, Ampho B
n=48 Participants
Participants receive Amphotericin B followed by Fluconazole in Stage 1
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2, Fluconazole 1600mg
Participants receive Fluconazole 1600mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Fluconazole 2000mg
Participants receive Fluconazole 2000mg induction dose in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2, Ampho B
Participants receive Amphotericin B followed by Fluconazole in Stage 2
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 and 4 Adverse Events
Sign/Symptom Events
|
23 Participants
|
16 Participants
|
32 Participants
|
24 Participants
|
—
|
—
|
—
|
|
Number of Participants With Grade 3 and 4 Adverse Events
Laboratory Events
|
27 Participants
|
12 Participants
|
26 Participants
|
30 Participants
|
—
|
—
|
—
|
Adverse Events
Stage 1: 1200mg Fluconazole
Serious events: 14 serious events
Other events: 22 other events
Deaths: 9 deaths
Stage 1: 1600mg Fluconazole
Serious events: 13 serious events
Other events: 26 other events
Deaths: 7 deaths
Stage 1: 2000mg Fluconazole
Serious events: 13 serious events
Other events: 24 other events
Deaths: 8 deaths
Stage 1: Ampho B
Serious events: 11 serious events
Other events: 24 other events
Deaths: 7 deaths
Stage 2: 1600mg Fluconazole
Serious events: 10 serious events
Other events: 24 other events
Deaths: 7 deaths
Stage 2: 2000mg Fluconazole
Serious events: 12 serious events
Other events: 24 other events
Deaths: 8 deaths
Stage 2: Ampho B
Serious events: 6 serious events
Other events: 24 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Stage 1: 1200mg Fluconazole
n=22 participants at risk
Participants receive Fluconazole 1200mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1: 1600mg Fluconazole
n=26 participants at risk
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1: 2000mg Fluconazole
n=24 participants at risk
Participants receive Fluconazole 2000mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1: Ampho B
n=24 participants at risk
Participants receive Amphotericin B followed by Fluconazole
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2: 1600mg Fluconazole
n=24 participants at risk
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2: 2000mg Fluconazole
n=24 participants at risk
Participants receive Fluconazole 2000mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2: Ampho B
n=24 participants at risk
Participants receive Amphotericin B followed by Fluconazole
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Weight decreased
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
General disorders
Death
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
General disorders
Pyrexia
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Immune system disorders
Immune reconstitution inflammatory syndrome
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Disseminated cryptococcosis
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Malaria
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Meningitis cryptococcal
|
22.7%
5/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
26.9%
7/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
16.7%
4/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Pneumonia
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Sepsis
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Septic shock
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Injury, poisoning and procedural complications
Overdose
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Nervous system disorders
Encephalopathy
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Nervous system disorders
Headache
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Nervous system disorders
Hemiparesis
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Nervous system disorders
Intracranial pressure increased
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Nervous system disorders
Seizure
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Nervous system disorders
Superior sagittal sinus thrombosis
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
Other adverse events
| Measure |
Stage 1: 1200mg Fluconazole
n=22 participants at risk
Participants receive Fluconazole 1200mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1: 1600mg Fluconazole
n=26 participants at risk
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1: 2000mg Fluconazole
n=24 participants at risk
Participants receive Fluconazole 2000mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 1: Ampho B
n=24 participants at risk
Participants receive Amphotericin B followed by Fluconazole
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
Stage 2: 1600mg Fluconazole
n=24 participants at risk
Participants receive Fluconazole 1600mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2: 2000mg Fluconazole
n=24 participants at risk
Participants receive Fluconazole 2000mg induction dose
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
|
Stage 2: Ampho B
n=24 participants at risk
Participants receive Amphotericin B followed by Fluconazole
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
|
|---|---|---|---|---|---|---|---|
|
Investigations
Blood sodium decreased
|
86.4%
19/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
80.8%
21/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
87.5%
21/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
83.3%
20/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
75.0%
18/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
75.0%
18/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
91.7%
22/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Haemoglobin decreased
|
36.4%
8/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
42.3%
11/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
37.5%
9/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
45.8%
11/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
33.3%
8/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
33.3%
8/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
70.8%
17/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Neutrophil count decreased
|
18.2%
4/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
30.8%
8/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
45.8%
11/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
58.3%
14/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
33.3%
8/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
41.7%
10/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Blood and lymphatic system disorders
Anaemia
|
13.6%
3/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Eye disorders
Conjunctival hyperaemia
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Eye disorders
Vision blurred
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Eye disorders
Visual impairment
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Anorectal swelling
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Gastritis
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Odynophagia
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Oral disorder
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
15.4%
4/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
16.7%
4/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
General disorders
Asthenia
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
General disorders
Chest pain
|
13.6%
3/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
General disorders
Fatigue
|
13.6%
3/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
General disorders
Malaise
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
16.7%
4/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
41.7%
10/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
General disorders
Pyrexia
|
31.8%
7/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
23.1%
6/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
29.2%
7/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
33.3%
8/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
16.7%
4/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Encephalitis cytomegalovirus
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Malaria
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Meningitis cryptococcal
|
27.3%
6/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
30.8%
8/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
37.5%
9/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
41.7%
10/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
33.3%
8/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Meningitis tuberculous
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Oral herpes
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
18.2%
4/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Pneumonia bacterial
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Pulmonary tuberculosis
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Septic shock
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Tuberculosis gastrointestinal
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Alanine aminotransferase increased
|
18.2%
4/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
19.2%
5/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
16.7%
4/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Aspartate aminotransferase increased
|
36.4%
8/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
19.2%
5/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
37.5%
9/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
29.2%
7/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood albumin decreased
|
86.4%
19/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
69.2%
18/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
75.0%
18/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
79.2%
19/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
79.2%
19/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
70.8%
17/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
87.5%
21/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood alkaline phosphatase increased
|
18.2%
4/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
29.2%
7/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood bicarbonate decreased
|
18.2%
4/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
34.6%
9/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
66.7%
16/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
41.7%
10/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
58.3%
14/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
41.7%
10/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood calcium decreased
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood creatine phosphokinase increased
|
13.6%
3/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood creatinine increased
|
22.7%
5/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
15.4%
4/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
33.3%
8/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
50.0%
12/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
29.2%
7/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
54.2%
13/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood glucose decreased
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood glucose increased
|
54.5%
12/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
26.9%
7/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
37.5%
9/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
29.2%
7/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
33.3%
8/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
33.3%
8/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood magnesium decreased
|
22.7%
5/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
16.7%
4/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
33.3%
8/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
37.5%
9/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood phosphorus decreased
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood potassium decreased
|
63.6%
14/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
26.9%
7/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
41.7%
10/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
54.2%
13/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
37.5%
9/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
54.2%
13/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood potassium increased
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Blood pressure increased
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Platelet count decreased
|
31.8%
7/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
19.2%
5/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
29.2%
7/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
33.3%
8/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
Weight decreased
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
16.7%
4/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Investigations
White blood cell count decreased
|
22.7%
5/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
11.5%
3/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
50.0%
12/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
13.6%
3/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
11.5%
3/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
16.7%
4/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Nervous system disorders
Altered state of consciousness
|
13.6%
3/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
11.5%
3/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Nervous system disorders
Headache
|
18.2%
4/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
15.4%
4/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
33.3%
8/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
29.2%
7/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
20.8%
5/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
29.2%
7/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Nervous system disorders
Seizure
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
16.7%
4/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Nervous system disorders
Somnolence
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Psychiatric disorders
Confusional state
|
18.2%
4/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
7.7%
2/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
16.7%
4/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
16.7%
4/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
4/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
15.4%
4/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
25.0%
6/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
27.3%
6/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
16.7%
4/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
16.7%
4/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
8.3%
2/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
4.5%
1/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
12.5%
3/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Vascular disorders
Hypertension
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
4.2%
1/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
|
Vascular disorders
Hypotension
|
9.1%
2/22 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
3.8%
1/26 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
0.00%
0/24 • Adverse event data were collected from study entry until end of study (24 weeks).
The protocol required reporting of all Grade \>= 3 signs/symptoms, all Grade \>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER