Trial Outcomes & Findings for Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB) (NCT NCT01404312)
NCT ID: NCT01404312
Last Updated: 2021-11-04
Results Overview
Incidence rate (events per 100 person-years) was estimated, and 95.1% confidence interval used to account for interim analysis of primary efficacy outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3000 participants
Primary outcome timeframe
From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Results posted on
2021-11-04
Participant Flow
Forty-five Clinical Research sites across 10 countries participated in the study. The first participant was randomized on May 23, 2012. Accrual closed on November 12, 2014 with 3,000 participants enrolled in the study.
Randomization was 1:1, and stratified by CD4 count (\< 100, 100-250, and \> 250 cells/mm\^3), and antiretroviral therapy status (receiving antiretroviral therapy or not receiving antiretroviral therapy at enrollment).
Participant milestones
| Measure |
RPT Plus INH Regimen (Arm A)
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily
|
INH Regimen (Arm B)
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
|---|---|---|
|
Overall Study
STARTED
|
1496
|
1504
|
|
Overall Study
COMPLETED
|
1198
|
1193
|
|
Overall Study
NOT COMPLETED
|
298
|
311
|
Reasons for withdrawal
| Measure |
RPT Plus INH Regimen (Arm A)
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily
|
INH Regimen (Arm B)
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
|---|---|---|
|
Overall Study
Death
|
21
|
27
|
|
Overall Study
Withdrawal by Subject
|
15
|
18
|
|
Overall Study
Participant Unable to get to clinic
|
93
|
103
|
|
Overall Study
Lost to Follow-up
|
115
|
111
|
|
Overall Study
Site closed
|
22
|
21
|
|
Overall Study
Participant not willing to adhere to req
|
31
|
29
|
|
Overall Study
Severe debilitation, unable to continue
|
1
|
2
|
Baseline Characteristics
Measured only in those participants who were taking antiretroviral therapy at entry.
Baseline characteristics by cohort
| Measure |
RPT Plus INH Regimen (Arm A)
n=1496 Participants
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily
|
INH Regimen (Arm B)
n=1504 Participants
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
Total
n=3000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
Peru
|
258 participants
n=1496 Participants
|
257 participants
n=1504 Participants
|
515 participants
n=3000 Participants
|
|
Body Mass Index (BMI)
|
24.6 kg/m^2
STANDARD_DEVIATION 5.2 • n=1496 Participants
|
24.5 kg/m^2
STANDARD_DEVIATION 5.3 • n=1504 Participants
|
24.5 kg/m^2
STANDARD_DEVIATION 5.2 • n=3000 Participants
|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 10.3 • n=1496 Participants
|
35.6 years
STANDARD_DEVIATION 10.3 • n=1504 Participants
|
35.7 years
STANDARD_DEVIATION 10.3 • n=3000 Participants
|
|
Age, Customized
Age at Entry · <=20 years
|
77 Participants
n=1496 Participants
|
70 Participants
n=1504 Participants
|
147 Participants
n=3000 Participants
|
|
Age, Customized
Age at Entry · >20, <=30 years
|
421 Participants
n=1496 Participants
|
455 Participants
n=1504 Participants
|
876 Participants
n=3000 Participants
|
|
Age, Customized
Age at Entry · >30, <=40 years
|
523 Participants
n=1496 Participants
|
514 Participants
n=1504 Participants
|
1037 Participants
n=3000 Participants
|
|
Age, Customized
Age at Entry · >40, <=50 years
|
342 Participants
n=1496 Participants
|
331 Participants
n=1504 Participants
|
673 Participants
n=3000 Participants
|
|
Age, Customized
Age at Entry · >50 years
|
133 Participants
n=1496 Participants
|
134 Participants
n=1504 Participants
|
267 Participants
n=3000 Participants
|
|
Sex: Female, Male
Female
|
802 Participants
n=1496 Participants
|
812 Participants
n=1504 Participants
|
1614 Participants
n=3000 Participants
|
|
Sex: Female, Male
Male
|
694 Participants
n=1496 Participants
|
692 Participants
n=1504 Participants
|
1386 Participants
n=3000 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White Non-Hispanic
|
16 Participants
n=1496 Participants
|
12 Participants
n=1504 Participants
|
28 Participants
n=3000 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black Non-Hispanic
|
992 Participants
n=1496 Participants
|
991 Participants
n=1504 Participants
|
1983 Participants
n=3000 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic (Regardless of Race)
|
361 Participants
n=1496 Participants
|
369 Participants
n=1504 Participants
|
730 Participants
n=3000 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian, Pacific Islander
|
122 Participants
n=1496 Participants
|
128 Participants
n=1504 Participants
|
250 Participants
n=3000 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Not Reported
|
5 Participants
n=1496 Participants
|
4 Participants
n=1504 Participants
|
9 Participants
n=3000 Participants
|
|
Region of Enrollment
Haiti
|
198 participants
n=1496 Participants
|
198 participants
n=1504 Participants
|
396 participants
n=3000 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=1496 Participants
|
46 participants
n=1504 Participants
|
91 participants
n=3000 Participants
|
|
Region of Enrollment
Malawi
|
106 participants
n=1496 Participants
|
108 participants
n=1504 Participants
|
214 participants
n=3000 Participants
|
|
Region of Enrollment
Botswana
|
210 participants
n=1496 Participants
|
212 participants
n=1504 Participants
|
422 participants
n=3000 Participants
|
|
Region of Enrollment
Brazil
|
102 participants
n=1496 Participants
|
98 participants
n=1504 Participants
|
200 participants
n=3000 Participants
|
|
Region of Enrollment
South Africa
|
307 participants
n=1496 Participants
|
309 participants
n=1504 Participants
|
616 participants
n=3000 Participants
|
|
Region of Enrollment
Zimbabwe
|
56 participants
n=1496 Participants
|
58 participants
n=1504 Participants
|
114 participants
n=3000 Participants
|
|
Region of Enrollment
Kenya
|
93 participants
n=1496 Participants
|
94 participants
n=1504 Participants
|
187 participants
n=3000 Participants
|
|
Region of Enrollment
Thailand
|
121 participants
n=1496 Participants
|
124 participants
n=1504 Participants
|
245 participants
n=3000 Participants
|
|
IV Drug Use
Never
|
1489 Participants
n=1496 Participants
|
1497 Participants
n=1504 Participants
|
2986 Participants
n=3000 Participants
|
|
IV Drug Use
Currently
|
2 Participants
n=1496 Participants
|
1 Participants
n=1504 Participants
|
3 Participants
n=3000 Participants
|
|
IV Drug Use
Previously
|
5 Participants
n=1496 Participants
|
6 Participants
n=1504 Participants
|
11 Participants
n=3000 Participants
|
|
Prior Tuberculosis History
Yes
|
82 Participants
n=1496 Participants
|
89 Participants
n=1504 Participants
|
171 Participants
n=3000 Participants
|
|
Prior Tuberculosis History
No
|
1414 Participants
n=1496 Participants
|
1415 Participants
n=1504 Participants
|
2829 Participants
n=3000 Participants
|
|
Screening CD4 counts
<100 cells/mm^3
|
37 Participants
n=1496 Participants
|
37 Participants
n=1504 Participants
|
74 Participants
n=3000 Participants
|
|
Screening CD4 counts
>=100,<=250 cells/mm^3
|
160 Participants
n=1496 Participants
|
165 Participants
n=1504 Participants
|
325 Participants
n=3000 Participants
|
|
Screening CD4 counts
>250 cells/mm^3
|
1299 Participants
n=1496 Participants
|
1302 Participants
n=1504 Participants
|
2601 Participants
n=3000 Participants
|
|
Antiretroviral Therapy (ART) at Entry
Efavirenz-based
|
650 Participants
n=1496 Participants
|
649 Participants
n=1504 Participants
|
1299 Participants
n=3000 Participants
|
|
Antiretroviral Therapy (ART) at Entry
Nevirapine-based
|
97 Participants
n=1496 Participants
|
100 Participants
n=1504 Participants
|
197 Participants
n=3000 Participants
|
|
Antiretroviral Therapy (ART) at Entry
Neither Efavirenz nor Nevirapine-based
|
3 Participants
n=1496 Participants
|
6 Participants
n=1504 Participants
|
9 Participants
n=3000 Participants
|
|
Antiretroviral Therapy (ART) at Entry
Not on ART
|
746 Participants
n=1496 Participants
|
749 Participants
n=1504 Participants
|
1495 Participants
n=3000 Participants
|
|
HIV-1 RNA Viral load among participants on ART at entry
Detectable
|
154 Participants
n=750 Participants • Measured only in those participants who were taking antiretroviral therapy at entry.
|
143 Participants
n=755 Participants • Measured only in those participants who were taking antiretroviral therapy at entry.
|
297 Participants
n=1505 Participants • Measured only in those participants who were taking antiretroviral therapy at entry.
|
|
HIV-1 RNA Viral load among participants on ART at entry
Undetectable
|
569 Participants
n=750 Participants • Measured only in those participants who were taking antiretroviral therapy at entry.
|
586 Participants
n=755 Participants • Measured only in those participants who were taking antiretroviral therapy at entry.
|
1155 Participants
n=1505 Participants • Measured only in those participants who were taking antiretroviral therapy at entry.
|
|
HIV-1 RNA Viral load among participants on ART at entry
Not Reported
|
27 Participants
n=750 Participants • Measured only in those participants who were taking antiretroviral therapy at entry.
|
26 Participants
n=755 Participants • Measured only in those participants who were taking antiretroviral therapy at entry.
|
53 Participants
n=1505 Participants • Measured only in those participants who were taking antiretroviral therapy at entry.
|
PRIMARY outcome
Timeframe: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)Population: All participants who started study treatment.
Incidence rate (events per 100 person-years) was estimated, and 95.1% confidence interval used to account for interim analysis of primary efficacy outcome.
Outcome measures
| Measure |
RPT Plus INH Regimen (Arm A)
n=1488 Participants
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.
|
INH Regimen (Arm B)
n=1498 Participants
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
|---|---|---|
|
Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause
|
0.6506 Events per 100 person-years
Interval 0.4242 to 0.877
|
0.6736 Events per 100 person-years
Interval 0.4428 to 0.9045
|
SECONDARY outcome
Timeframe: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)Population: All participants who started study treatment
Occurrence of any SAE that meets the ICH definition of an SAE
Outcome measures
| Measure |
RPT Plus INH Regimen (Arm A)
n=1488 Participants
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.
|
INH Regimen (Arm B)
n=1498 Participants
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
|---|---|---|
|
Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs
No SAE occurred
|
1405 Participants
|
1390 Participants
|
|
Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs
At least one SAE occurred
|
83 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)Population: All participants who started study treatment
Targeted adverse events include each new grade 3 or 4 laboratory value or sign or symptom that is at least one grade increase from baseline for the following: nausea and vomiting; cutaneous; drug-associated fever; elevated aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]), or bilirubin; and peripheral neuropathy
Outcome measures
| Measure |
RPT Plus INH Regimen (Arm A)
n=1488 Participants
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.
|
INH Regimen (Arm B)
n=1498 Participants
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
|---|---|---|
|
Number of Participants With a Targeted Adverse Event
No Targeted Safety Event
|
1445 Participants
|
1446 Participants
|
|
Number of Participants With a Targeted Adverse Event
Occurrence of Targeted Safety Event
|
43 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: From entry to end of treatment (up to 8 weeks for Arm A; up to 54 weeks for Arm B)Population: All participants who started study treatment
Ordered categories include: 1. Premature permanent treatment discontinuation 2. Treatment hold for more than 7 consecutive days 3. None of the above
Outcome measures
| Measure |
RPT Plus INH Regimen (Arm A)
n=1488 Participants
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.
|
INH Regimen (Arm B)
n=1498 Participants
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
|---|---|---|
|
Number of Participants in Each Category of Ordered Categorical Variable Indicating Most Stringent Level of Study Drug Management Due to Toxicity That Was Required Over the Treatment Period
Premature permanent treatment discontinuation
|
16 Participants
|
25 Participants
|
|
Number of Participants in Each Category of Ordered Categorical Variable Indicating Most Stringent Level of Study Drug Management Due to Toxicity That Was Required Over the Treatment Period
Treatment held for more than 7 days
|
11 Participants
|
31 Participants
|
|
Number of Participants in Each Category of Ordered Categorical Variable Indicating Most Stringent Level of Study Drug Management Due to Toxicity That Was Required Over the Treatment Period
None of the above
|
1461 Participants
|
1442 Participants
|
SECONDARY outcome
Timeframe: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)Population: All Participants who started study treatment
Data table estimates for percentage who died by each time point were estimated using Kaplan-Meier at 1, 2, 3, and 4 years post-entry.
Outcome measures
| Measure |
RPT Plus INH Regimen (Arm A)
n=1488 Participants
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.
|
INH Regimen (Arm B)
n=1498 Participants
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
|---|---|---|
|
Cumulative Incidence of Death From Any Cause
1 year post-entry
|
0.35 events per 100 participants
|
0.63 events per 100 participants
|
|
Cumulative Incidence of Death From Any Cause
2 years post-entry
|
0.49 events per 100 participants
|
1.15 events per 100 participants
|
|
Cumulative Incidence of Death From Any Cause
3 years post-entry
|
1.05 events per 100 participants
|
1.62 events per 100 participants
|
|
Cumulative Incidence of Death From Any Cause
4 years post-entry
|
2.00 events per 100 participants
|
2.29 events per 100 participants
|
SECONDARY outcome
Timeframe: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)Population: All participants who started study treatment
Cumulative incidence function estimated nonparametrically, treating TB-related deaths as competing risks.
Outcome measures
| Measure |
RPT Plus INH Regimen (Arm A)
n=1488 Participants
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.
|
INH Regimen (Arm B)
n=1498 Participants
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
|---|---|---|
|
Cumulative Incidence of Death Due to a Non-TB Event
Cumulative incidence by 3 years post-randomization
|
0.9 events per 100 participants
|
1.5 events per 100 participants
|
|
Cumulative Incidence of Death Due to a Non-TB Event
Cumulative incidence by 1 year post-randomization
|
0.3 events per 100 participants
|
0.5 events per 100 participants
|
|
Cumulative Incidence of Death Due to a Non-TB Event
Cumulative incidence by 2 years post-randomization
|
0.4 events per 100 participants
|
1.0 events per 100 participants
|
|
Cumulative Incidence of Death Due to a Non-TB Event
Cumulative incidence by 4 years post-randomization
|
1.6 events per 100 participants
|
2.0 events per 100 participants
|
SECONDARY outcome
Timeframe: After TB diagnosisPopulation: Participants with a culture-confirmed TB diagnosis who underwent drug susceptibility testing
Among MTB-diagnosed participants who underwent drug-susceptibility testing, the number who had any resistance to a particular drug.
Outcome measures
| Measure |
RPT Plus INH Regimen (Arm A)
n=15 Participants
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.
|
INH Regimen (Arm B)
n=12 Participants
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
|---|---|---|
|
Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
Rifampin · Developed Resistance
|
1 Participants
|
1 Participants
|
|
Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
Rifampin · Did not Develop Resistance
|
14 Participants
|
11 Participants
|
|
Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
Isoniazid · Developed Resistance
|
2 Participants
|
1 Participants
|
|
Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
Isoniazid · Did not Develop Resistance
|
12 Participants
|
11 Participants
|
|
Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
Ethambutol · Developed Resistance
|
0 Participants
|
1 Participants
|
|
Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
Ethambutol · Did not Develop Resistance
|
7 Participants
|
7 Participants
|
|
Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
Pyrazinamide · Developed Resistance
|
0 Participants
|
0 Participants
|
|
Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
Pyrazinamide · Did not Develop Resistance
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Measured at Weeks 0, 2, 4, and 16Population: Only measured in the first 90 participants randomized to Arm A who entered the study taking EFV and who meet dose timing criteria; and, under Version 2.0 of the protocol, at Weeks 0, 2, 4, and 16 in the first 30 participants randomized to Arm A who enter the study taking EFV and who meet dose timing criteria.
Mean and standard deviation. Week 16 samples have not yet been analyzed because the metabolite assay is being validated, and requires submission for approval by the Clinical Pharmacology Quality Assurance Program. Analysis of week 16 samples are anticipated to be available in September 2019.
Outcome measures
| Measure |
RPT Plus INH Regimen (Arm A)
n=111 Participants
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.
|
INH Regimen (Arm B)
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
|---|---|---|
|
Efavirenz (EFV) Plasma Concentrations in Arm A
Week 0
|
3787 nanograms per mL
Standard Deviation 4922
|
—
|
|
Efavirenz (EFV) Plasma Concentrations in Arm A
Week 2
|
3870 nanograms per mL
Standard Deviation 7011
|
—
|
|
Efavirenz (EFV) Plasma Concentrations in Arm A
Week 4
|
4082 nanograms per mL
Standard Deviation 4916
|
—
|
SECONDARY outcome
Timeframe: Measured at Weeks 0, 2, and 4Population: Only measured in the first 90 participants randomized to Arm A who enter the study taking NVP and who meet dose timing criteria. For weeks 0, 2, 4, some samples were missing or contaminated.
Mean and standard deviation
Outcome measures
| Measure |
RPT Plus INH Regimen (Arm A)
n=90 Participants
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.
|
INH Regimen (Arm B)
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
|---|---|---|
|
Nevirapine (NVP) Plasma Concentrations in Arm A
Week0
|
7573 nanograms per mL
Standard Deviation 3789
|
—
|
|
Nevirapine (NVP) Plasma Concentrations in Arm A
Week 2
|
6234 nanograms per mL
Standard Deviation 4283
|
—
|
|
Nevirapine (NVP) Plasma Concentrations in Arm A
Week 4
|
5797 nanograms per mL
Standard Deviation 3963
|
—
|
SECONDARY outcome
Timeframe: Measured at weeks 0, 2 and 4Population: Outcome measure was not assessed because no participants enrolled under version 2.0 of the protocol were on Efavirenz at study entry.
For Version 2.0 of the protocol only, measured in the first 90 participants randomized to Arm B who enter the study taking EFV and who meet dose timing criteria. Outcome measure was not assessed because no participants enrolled under version 2.0 of the protocol were on Efavirenz at study entry.
Outcome measures
Outcome data not reported
Adverse Events
RPT Plus INH Regimen (Arm A)
Serious events: 40 serious events
Other events: 1051 other events
Deaths: 21 deaths
INH Regimen (Arm B)
Serious events: 68 serious events
Other events: 1042 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
RPT Plus INH Regimen (Arm A)
n=1496 participants at risk
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg received 600 mg once daily (administered as four 150-mg tablets).
|
INH Regimen (Arm B)
n=1504 participants at risk
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily
INH Regimen (Arm B) Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.13%
2/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.20%
3/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.33%
5/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.13%
2/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Gastrointestinal disorders
Vomiting
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
General disorders
Death
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.13%
2/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.13%
2/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Hepatobiliary disorders
Hepatitis
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.13%
2/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Acute hepatitis B
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Bacterial sepsis
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Bone tuberculosis
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Dengue haemorrhagic fever
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.13%
2/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Gastroenteritis
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
HIV infection
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Orchitis
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Pneumonia
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.13%
2/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Retroviral infection
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Septic shock
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Typhus
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Blood creatinine increased
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Hepatic enzyme increased
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.47%
7/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Transaminases increased
|
0.13%
2/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.13%
2/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.13%
2/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Nervous system disorders
Idiopathic intracranial hypertension
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.27%
4/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Nervous system disorders
Superior sagittal sinus thrombosis
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.13%
2/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Psychiatric disorders
Suicide attempt
|
0.13%
2/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Renal and urinary disorders
Renal impairment
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.07%
1/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.00%
0/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.13%
2/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
0.07%
1/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
Other adverse events
| Measure |
RPT Plus INH Regimen (Arm A)
n=1496 participants at risk
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Rifapentine (RPT): RPT dosing was based on participants' weight:
Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
Participants who weighed greater than 45 kg received 600 mg once daily (administered as four 150-mg tablets).
|
INH Regimen (Arm B)
n=1504 participants at risk
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily
INH Regimen (Arm B) Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
81/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
5.5%
83/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
101/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
7.2%
108/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
General disorders
Pyrexia
|
13.2%
198/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
12.4%
187/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
93/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
5.6%
84/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Pharyngitis
|
5.9%
89/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
3.8%
57/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Tonsillitis
|
5.3%
79/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
4.3%
65/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
118/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
7.8%
117/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Alanine aminotransferase increased
|
6.8%
102/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
8.0%
121/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Aspartate aminotransferase increased
|
6.3%
94/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
7.8%
118/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Blood albumin decreased
|
6.5%
97/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
8.3%
125/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.6%
99/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
6.6%
99/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Blood pressure increased
|
5.5%
83/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
4.2%
63/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Blood sodium decreased
|
14.6%
219/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
13.3%
200/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Blood sodium increased
|
5.8%
87/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
7.1%
107/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Haemoglobin decreased
|
7.5%
112/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
8.0%
120/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Neutrophil count decreased
|
12.6%
189/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
9.7%
146/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Investigations
Weight decreased
|
4.9%
74/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
7.0%
105/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Nervous system disorders
Headache
|
10.4%
155/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
9.9%
149/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
6.2%
93/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
6.8%
102/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.0%
254/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
15.8%
238/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.4%
125/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
8.2%
123/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.5%
202/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
11.0%
166/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.2%
122/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
8.6%
130/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
|
Vascular disorders
Hypertension
|
6.4%
95/1496 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
5.0%
75/1504 • From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
|
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