Trial Outcomes & Findings for Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS (NCT NCT01435018)
NCT ID: NCT01435018
Last Updated: 2021-10-20
Results Overview
Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
334 participants
Primary outcome timeframe
From study entry to week 48
Results posted on
2021-10-20
Participant Flow
Participants were recruited from October 2013 to March 2018 at 11 sites from Africa and South America (Brazil).
Participant milestones
| Measure |
BV+ART
Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
ET+ART
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Overall Study
STARTED
|
135
|
60
|
139
|
|
Overall Study
COMPLETED
|
88
|
26
|
98
|
|
Overall Study
NOT COMPLETED
|
47
|
34
|
41
|
Reasons for withdrawal
| Measure |
BV+ART
Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
ET+ART
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Overall Study
Death
|
37
|
18
|
25
|
|
Overall Study
Site is closing
|
4
|
9
|
7
|
|
Overall Study
Withdrew consent
|
0
|
3
|
1
|
|
Overall Study
Not willing to adhere to requirements
|
0
|
2
|
3
|
|
Overall Study
Not able to get to clinic
|
2
|
0
|
2
|
|
Overall Study
Severe debilitation, unable to continue
|
0
|
0
|
1
|
|
Overall Study
Unable to contact participant/parent
|
1
|
1
|
1
|
|
Overall Study
Enrollment Violation
|
0
|
1
|
0
|
|
Overall Study
Never started chemotherapy
|
3
|
0
|
1
|
Baseline Characteristics
Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS
Baseline characteristics by cohort
| Measure |
BV+ART
n=132 Participants
Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
Total
n=329 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35 years
n=5 Participants
|
35 years
n=7 Participants
|
35 years
n=5 Participants
|
35 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
315 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
130 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
324 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Malawi
|
54 participants
n=5 Participants
|
27 participants
n=7 Participants
|
56 participants
n=5 Participants
|
137 participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
7 participants
n=5 Participants
|
0 participants
n=7 Participants
|
8 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Zimbabwe
|
32 participants
n=5 Participants
|
18 participants
n=7 Participants
|
29 participants
n=5 Participants
|
79 participants
n=4 Participants
|
|
Region of Enrollment
Uganda
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Region of Enrollment
Kenya
|
27 participants
n=5 Participants
|
2 participants
n=7 Participants
|
29 participants
n=5 Participants
|
58 participants
n=4 Participants
|
|
CD4 Cell Count, categorized
<100 cells/mm^3
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
CD4 Cell Count, categorized
>=100 cells/mm^3
|
106 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
259 Participants
n=4 Participants
|
|
Karnofsky Performance Score
60
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Karnofsky Performance Score
70
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Karnofsky Performance Score
80
|
41 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Karnofsky Performance Score
90
|
79 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
|
Karnofsky Performance Score
100
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
CD4 Cell Count
|
232 cells/mm^3
n=5 Participants
|
216 cells/mm^3
n=7 Participants
|
231 cells/mm^3
n=5 Participants
|
229 cells/mm^3
n=4 Participants
|
|
HIV-1 RNA, continuous
|
4.6 Log10 copies/mL
n=5 Participants
|
4.9 Log10 copies/mL
n=7 Participants
|
4.0 Log10 copies/mL
n=5 Participants
|
4.4 Log10 copies/mL
n=4 Participants
|
|
HIV-1 RNA, categorized
<400 copies/mL
|
29 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
HIV-1 RNA, categorized
400 to <1,000 copies/mL
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
HIV-1 RNA, categorized
1000 to <10,000 copies/mL
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
HIV-1 RNA, categorized
>=10,000 copies/mL
|
77 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
190 Participants
n=4 Participants
|
|
Number of Cutaneous KS Lesions
<=50 lesions
|
32 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Number of Cutaneous KS Lesions
>50 lesions
|
100 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
225 Participants
n=4 Participants
|
|
Presence of Oral Cavity KS Lesions
|
90 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
206 Participants
n=4 Participants
|
|
Presence of Lower Limb Edema
|
71 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Presence of Lower Limb Edema in Both Limbs
|
39 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Presence of Visceral KS
|
36 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART
|
19.7 Cumulative events per 100 persons
Interval 6.3 to 33.1
|
49.8 Cumulative events per 100 persons
Interval 32.4 to 67.3
|
—
|
PRIMARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART
|
44.1 Cumulative events per 100 persons
Interval 35.0 to 53.2
|
64.2 Cumulative events per 100 persons
Interval 55.4 to 73.0
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to date of death. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48.
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART
|
25.6 Cumulative events per 100 persons
Interval 10.9 to 40.3
|
10.7 Cumulative events per 100 persons
Interval 2.6 to 18.8
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to the death date. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48.
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART
|
18.5 Cumulative events per 100 persons
Interval 11.5 to 25.5
|
10.3 Cumulative events per 100 persons
Interval 5.0 to 15.7
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART
|
69.8 Cumulative events per 100 persons
Interval 54.2 to 85.3
|
41.2 Cumulative events per 100 persons
Interval 21.8 to 60.7
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART
|
43.9 Cumulative events per 100 persons
Interval 34.1 to 53.8
|
25.7 Cumulative events per 100 persons
Interval 17.1 to 34.3
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48.
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART
|
15.2 Cumulative events per 100 persons
Interval 3.8 to 26.6
|
28.6 Cumulative events per 100 persons
Interval 12.0 to 45.3
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48.
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART
|
17.9 Cumulative events per 100 persons
Interval 10.7 to 25.1
|
19.6 Cumulative events per 100 persons
Interval 12.3 to 26.9
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
Virologic failure is defined as two successive measurements of plasma HIV-1 RNA \>=1000 copies/mL at week 12 to week 24 or RNA \>=400 copies/mL at week 24 or later.
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART
|
7.8 Cumulative events per 100 persons
Interval 0.0 to 16.4
|
0.0 Cumulative events per 100 persons
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
Virologic failure is defined as two successive measurements of plasma HIV-1 RNA \>=1000 copies/mL at week 12 to week 24 or RNA \>=400 copies/mL at week 24 or later.
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART
|
7.4 Cumulative events per 100 persons
Interval 2.5 to 12.3
|
1.8 Cumulative events per 100 persons
Interval 0.0 to 4.2
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 12Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm\^3 above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression.
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for ET+ART vs. PTX+ART
|
6 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 12Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm\^3 above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression.
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for BV+ART vs. PTX+ART
|
2 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for ET+ART vs. PTX+ART
|
72.4 Cumulative events per 100 persons
Interval 58.1 to 86.8
|
54.6 Cumulative events per 100 persons
Interval 35.8 to 73.4
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for BV+ART vs. PTX+ART
|
56.7 Cumulative events per 100 persons
Interval 47.6 to 65.7
|
42.1 Cumulative events per 100 persons
Interval 33.0 to 51.1
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for ET+ART vs. PTX+ART
|
77.5 Cumulative events per 100 persons
Interval 63.8 to 91.3
|
54.6 Cumulative events per 100 persons
Interval 35.8 to 73.4
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for BV+ART vs. PTX+ART
|
60.9 Cumulative events per 100 persons
Interval 51.9 to 69.8
|
42.0 Cumulative events per 100 persons
Interval 33.0 to 51.0
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for ET+ART vs. PTX+ART
|
57.6 Cumulative events per 100 persons
Interval 45.0 to 70.2
|
33.9 Cumulative events per 100 persons
Interval 21.8 to 46.0
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for BV+ART vs. PTX+ART
|
54.5 Cumulative events per 100 persons
Interval 46.1 to 63.0
|
36.2 Cumulative events per 100 persons
Interval 28.2 to 44.3
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy.
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of Change in KS Treatment by Week 48 for ET+ART vs. PTX+ART
|
59.5 Cumulative events per 100 persons
Interval 41.5 to 77.5
|
26.0 Cumulative events per 100 persons
Interval 8.8 to 43.3
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy.
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of Change in KS Treatment by Week 48 for BV+ART vs. PTX+ART
|
32.5 Cumulative events per 100 persons
Interval 23.3 to 41.7
|
18.9 Cumulative events per 100 persons
Interval 11.2 to 26.6
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 240Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later.
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of Death for ET+ART vs. PTX+ART
|
25.6 Cumulative events per 100 persons
Interval 10.9 to 40.3
|
10.7 Cumulative events per 100 persons
Interval 2.6 to 18.8
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 240Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later.
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Cumulative Rate of Death for BV+ART vs PTX+ART
|
18.5 Cumulative events per 100 persons
Interval 11.5 to 25.5
|
10.3 Cumulative events per 100 persons
Interval 5.0 to 15.7
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 240Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or the participant's off study week, whichever is later. The 25-th percentile and hazard ratio are presented.
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Time to IERC-confirmed KS Progression or Death for ET+ART vs. PTX+ART
|
17.9 weeks
Interval 8.9 to 22.0
|
30.0 weeks
Interval 24.9 to 43.7
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 240Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or at the participant's off study week, whichever is later.The 25-th percentile and hazard ratio are presented.
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Time to IERC-confirmed KS Progression or Death for BV+ART vs. PTX+ART
|
24.7 weeks
Interval 21.3 to 30.0
|
38.6 weeks
Interval 32.9 to 57.9
|
—
|
SECONDARY outcome
Timeframe: From study entry up to week 144Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Number of Participants With Objective Response for ET+ART vs. PTX+ART
|
18 Participants
|
34 Participants
|
—
|
SECONDARY outcome
Timeframe: From study entry up to week 144Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Number of Participants With Objective Response for BV+ART vs. PTX+ART
|
80 Participants
|
91 Participants
|
—
|
SECONDARY outcome
Timeframe: From study entry up to week 144Population: All eligible participants who initiated study chemotherapy with complete of partial KS response in Step 1 as of March 2016.
Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented.
Outcome measures
| Measure |
ET+ART
n=18 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=34 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Duration of Objective Response for ET+ART vs. PTX+ART
|
10.1 weeks
Interval 3.0 to 24.0
|
19.9 weeks
Interval 12.0 to 46.1
|
—
|
SECONDARY outcome
Timeframe: From study entry up to week 144Population: All eligible participants who initiated study chemotherapy with complete of partial KS response in Step 1 as of March 2018.
Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented.
Outcome measures
| Measure |
ET+ART
n=80 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=91 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Duration of Objective Response for BV+ART vs. PTX+ART
|
21.0 weeks
Interval 12.0 to 30.6
|
45.7 weeks
Interval 22.4 to 56.7
|
—
|
SECONDARY outcome
Timeframe: Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of SPN for ET+ART was only done at screening, weeks 9 and 21.Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
SPN consists of three assessments: (1) pain, aching or burning in feet, legs, (2) "pins and needles" in feet, legs, and (3) numbness (lack of feeling) in feet, legs. SPN is graded on a severity scale from 0 (not present), 1 (mild) to 10 (severe). Presence of SPN is defined as having grade \>=1 in at least one of the three assessments.
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Number of Participants With Symptomatic Peripheral Neuropathy (SPN)
Screening
|
76 Participants
|
24 Participants
|
59 Participants
|
|
Number of Participants With Symptomatic Peripheral Neuropathy (SPN)
Week 3
|
62 Participants
|
0 Participants
|
34 Participants
|
|
Number of Participants With Symptomatic Peripheral Neuropathy (SPN)
Week 6
|
46 Participants
|
0 Participants
|
32 Participants
|
|
Number of Participants With Symptomatic Peripheral Neuropathy (SPN)
Week 9
|
40 Participants
|
14 Participants
|
27 Participants
|
|
Number of Participants With Symptomatic Peripheral Neuropathy (SPN)
Week 12
|
36 Participants
|
0 Participants
|
23 Participants
|
|
Number of Participants With Symptomatic Peripheral Neuropathy (SPN)
Week 15
|
26 Participants
|
0 Participants
|
16 Participants
|
|
Number of Participants With Symptomatic Peripheral Neuropathy (SPN)
Week 18
|
25 Participants
|
0 Participants
|
15 Participants
|
|
Number of Participants With Symptomatic Peripheral Neuropathy (SPN)
Week 21
|
30 Participants
|
4 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of PN for ET+ART was only done at screening, weeks 9 and 21.Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
Presence of PN is defined as having all of the following results: presence of symptomatic PN, abnormal perception of vibrations, and absent or hypoactive deep tendon reflexes.
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Number of Participants With Peripheral Neuropathy (PN)
Screening
|
7 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Peripheral Neuropathy (PN)
Week 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Peripheral Neuropathy (PN)
Week 6
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Peripheral Neuropathy (PN)
Week 9
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Peripheral Neuropathy (PN)
Week 12
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Peripheral Neuropathy (PN)
Week 15
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Peripheral Neuropathy (PN)
Week 18
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Peripheral Neuropathy (PN)
Week 21
|
5 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From study entry to week 240Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
Adverse events classified by the site personnel as possibly, probably or definitely related to ART or chemotherapy.
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Number of Participants With Treatment-related Toxicities and Adverse Events (AEs)
Any Laboratory, Diagnosis or Signs/Symptoms
|
32 Participants
|
25 Participants
|
48 Participants
|
|
Number of Participants With Treatment-related Toxicities and Adverse Events (AEs)
Any Laboratory
|
27 Participants
|
25 Participants
|
39 Participants
|
|
Number of Participants With Treatment-related Toxicities and Adverse Events (AEs)
Any Diagnosis
|
12 Participants
|
10 Participants
|
16 Participants
|
|
Number of Participants With Treatment-related Toxicities and Adverse Events (AEs)
Any Signs/Symptoms
|
9 Participants
|
5 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 12, 24, 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2016.
Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count.
Outcome measures
| Measure |
ET+ART
n=59 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART
Week 12 CD4 change
|
37 cells/mm^3
Interval -4.0 to 83.0
|
47 cells/mm^3
Interval 12.0 to 97.0
|
—
|
|
Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART
Week 24 CD4 change
|
106 cells/mm^3
Interval -4.0 to 136.0
|
95 cells/mm^3
Interval 24.0 to 179.0
|
—
|
|
Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART
Week 48 CD4 change
|
69 cells/mm^3
Interval 19.0 to 122.0
|
157 cells/mm^3
Interval 25.0 to 338.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, weeks 12, 24, 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count.
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART
Week 12 CD4 change
|
21 cells/mm^3
Interval -43.0 to 70.0
|
37 cells/mm^3
Interval -6.0 to 97.0
|
—
|
|
Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART
Week 24 CD4 change
|
43 cells/mm^3
Interval -25.0 to 110.0
|
65 cells/mm^3
Interval -1.0 to 159.0
|
—
|
|
Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART
Week 48 CD4 change
|
112 cells/mm^3
Interval 11.0 to 172.0
|
105 cells/mm^3
Interval 21.0 to 177.0
|
—
|
SECONDARY outcome
Timeframe: At Weeks 6, 12, 18, 30 and 48Population: All eligible participants who initiated study chemotherapy with available data as of March 2018.
ART adherence is based on participant's recall of the number of missed ART doses for the past month. Perfect adherence is defined as having zero missed ART doses.
Outcome measures
| Measure |
ET+ART
n=132 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=59 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=138 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Self-reported Adherence to ART Therapy
Week 48 Perfect adherence
|
13 Participants
|
0 Participants
|
20 Participants
|
|
Self-reported Adherence to ART Therapy
Week 6 Perfect Adherence
|
101 Participants
|
43 Participants
|
106 Participants
|
|
Self-reported Adherence to ART Therapy
Week 12 Perfect Adherence
|
101 Participants
|
36 Participants
|
103 Participants
|
|
Self-reported Adherence to ART Therapy
Week 18 Perfect adherence
|
85 Participants
|
29 Participants
|
97 Participants
|
|
Self-reported Adherence to ART Therapy
Week 30 Perfect adherence
|
66 Participants
|
13 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: From study entry to week 240Population: The corresponding outcome measure was withdrawn.
Funding for oral KS objectives including data and sample collection was withdrawn during the study conduct.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, weeks 60, 120, 180, 240Population: The corresponding outcome measure was withdrawn.
Funding for oral KS objectives including data and sample collection was withdrawn during the study conduct.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Step 2 study entry to Step 2 discontinuation, up to 144 weeksPopulation: All eligible participants who entered Step 2 with available data as of March 2018.
IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA \>=1000 copies/mL at week 12 to week 24 or RNA \>=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 2 treatment arm.
Outcome measures
| Measure |
ET+ART
n=10 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=1 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=9 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2
With IERC-confirmed KS progression
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2
With dose-limiting toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2
Died
|
1 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2
With AIDS-defining events
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2
With virologic failure
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2
With objective response
|
7 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From Step 3 study entry to Step 3 discontinuation, up to 144 weeksPopulation: All eligible participants who entered Step 3 with available data as of March 2018.
IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA \>=1000 copies/mL at week 12 to week 24 or RNA \>=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 3 treatment arm.
Outcome measures
| Measure |
ET+ART
n=29 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=6 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=42 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3
With IERC-confirmed KS progression
|
6 Participants
|
2 Participants
|
8 Participants
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3
With dose-limiting toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3
Died
|
3 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3
With AIDS-defining events
|
5 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3
With virologic failure
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3
With objective response
|
18 Participants
|
5 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: From Step 4 study entry to Step 4 discontinuation, up to 96 weeksPopulation: All eligible participants who entered Step 4 with available data as of March 2018.
IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA \>=1000 copies/mL at week 12 to week 24 or RNA \>=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 4 treatment arm.
Outcome measures
| Measure |
ET+ART
n=5 Participants
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
n=6 Participants
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
PTX+ART
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4
With IERC-confirmed KS progression
|
2 Participants
|
3 Participants
|
—
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4
With dose-limiting toxicity
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4
Died
|
3 Participants
|
2 Participants
|
—
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4
With AIDS-defining events
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4
With virologic failure
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4
With objective response
|
3 Participants
|
3 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, weeks 60, 120, 180, 240The protocol did not distinguish between outcome measures essential to the primary publication and those of lesser importance and priority which are not the focus of the study but intended for subsequent publications of exploratory analyses, conditional on primary results and additional funding. This outcome measure was listed under secondary outcome measures in the study protocol but was intended for an exploratory analysis to compare measures of quality of life in ET+ART, BV+ART and PTX+ART.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 24-48 hours after 2nd chemo-therapy cycle beginsThe protocol did not distinguish between outcome measures essential to the primary publication and those of lesser importance and priority which are not the focus of the study but intended for subsequent publications of exploratory analyses, conditional on primary results and additional funding. This outcome measure was listed under secondary outcome measures in the study protocol but was intended for an exploratory analysis to evaluate the relationship between response of KS to therapy and development of KS-IRIS with immunohistochemical markers of viral and cellular gene expression in KS tumors. The laboratory assays for this outcome measure have not been completed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, weeks 60, 120, 180, 240The protocol did not distinguish between outcome measures essential to the primary publication and those of lesser importance and priority which are not the focus of the study but intended for subsequent publications of exploratory analyses, conditional on primary results and additional funding. This outcome measure was listed under secondary outcome measures in the study protocol but was intended for an exploratory analysis to evaluate the relationship between response of KS to therapy and development of KS-IRIS with RNA levels for KSHV genes in tumor biopsies. The laboratory assays for this outcome measure have not been completed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, weeks 60, 120, 180, 240The protocol did not distinguish between outcome measures essential to the primary publication and those of lesser importance and priority which are not the focus of the study but intended for subsequent publications of exploratory analyses, conditional on primary results and additional funding. This outcome measure was listed under secondary outcome measures in the study protocol but was intended for an exploratory analysis to evaluate the relationship between response of KS to therapy and development of KS-IRIS with cellular and humoral markers of immune function and activation. The laboratory assays for this outcome measure have not been completed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, weeks 60, 120, 180, 240The protocol did not distinguish between outcome measures essential to the primary publication and those of lesser importance and priority which are not the focus of the study but intended for subsequent publications of exploratory analyses, conditional on primary results and additional funding. This outcome measure was listed under secondary outcome measures in the study protocol but was intended for an exploratory analysis to investigate the relationship between plasma and PBMC KSHV viral load. The laboratory assays for this outcome measure have not been completed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, weeks 60, 120, 180, 240The protocol did not distinguish between outcome measures essential to the primary publication and those of lesser importance and priority which are not the focus of the study but intended for subsequent publications of exploratory analyses, conditional on primary results and additional funding. This outcome measure was listed under secondary outcome measures in the study protocol but was intended for an exploratory analysis to investigate the relationship between plasma and PBMC KSHV viral load. The laboratory assays for this outcome measure have not been completed.
Outcome measures
Outcome data not reported
Adverse Events
Bleomycin Plus Vincristine (BV) Plus Co-formulated EFV/FTC/TDF
Serious events: 54 serious events
Other events: 130 other events
Deaths: 37 deaths
Etoposide (ET) Plus Co-formulated EFV/FTC/TDF
Serious events: 33 serious events
Other events: 58 other events
Deaths: 33 deaths
Paclitaxel (PTX) Plus Co-formulated EFV/FTC/TDF
Serious events: 55 serious events
Other events: 133 other events
Deaths: 55 deaths
Serious adverse events
| Measure |
Bleomycin Plus Vincristine (BV) Plus Co-formulated EFV/FTC/TDF
n=132 participants at risk
Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
Etoposide (ET) Plus Co-formulated EFV/FTC/TDF
n=59 participants at risk
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
Paclitaxel (PTX) Plus Co-formulated EFV/FTC/TDF
n=138 participants at risk
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Investigations
Neutrophil count decreased
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.8%
9/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.4%
2/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.8%
8/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.3%
3/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
10.2%
6/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.9%
4/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Death
|
5.3%
7/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.4%
2/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.6%
5/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Drowning
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Pyrexia
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Abscess
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Bacterial sepsis
|
4.5%
6/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.8%
4/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
4.3%
6/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Cellulitis
|
1.5%
2/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Central nervous system infection
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Chronic hepatitis B
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Extrapulmonary tuberculosis
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.4%
2/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Gangrene
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
2/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.4%
2/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
HIV infection WHO clinical stage IV
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Immune reconstitution inflammatory syndrome associated tuberculosis
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Malaria
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Meningitis
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Meningitis cryptococcal
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Osteomyelitis
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pneumonia
|
3.0%
4/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.4%
2/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
4.3%
6/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pneumonia bacterial
|
3.0%
4/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.4%
2/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.2%
3/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Sepsis
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Septic shock
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Urosepsis
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Aspartate aminotransferase increased
|
1.5%
2/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.4%
2/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.2%
3/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.4%
2/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Hepatic enzyme increased
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Transaminases increased
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Weight decreased
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.4%
2/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
9.8%
13/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
16.9%
10/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.5%
9/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Seizure
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion complete
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Psychiatric disorders
Completed suicide
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
2/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
Other adverse events
| Measure |
Bleomycin Plus Vincristine (BV) Plus Co-formulated EFV/FTC/TDF
n=132 participants at risk
Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
Etoposide (ET) Plus Co-formulated EFV/FTC/TDF
n=59 participants at risk
Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
Paclitaxel (PTX) Plus Co-formulated EFV/FTC/TDF
n=138 participants at risk
Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
5/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
10.2%
6/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.2%
3/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
5/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
8.5%
5/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.5%
9/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
9/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
13.6%
8/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
12.3%
17/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
3/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.1%
3/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
13/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
15.3%
9/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
9.4%
13/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Asthenia
|
5.3%
7/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.4%
2/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.9%
4/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Chest pain
|
9.8%
13/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
8.5%
5/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
9.4%
13/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Malaise
|
2.3%
3/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.1%
3/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.9%
4/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Mucosal discolouration
|
6.8%
9/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.8%
4/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Oedema peripheral
|
12.9%
17/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.1%
3/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
9.4%
13/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Pain
|
9.8%
13/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
8.5%
5/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
4.3%
6/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Peripheral swelling
|
4.5%
6/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
8.5%
5/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.6%
5/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
General disorders
Pyrexia
|
19.7%
26/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
23.7%
14/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
15.9%
22/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Bacterial sepsis
|
9.1%
12/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
8.5%
5/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.6%
5/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
2/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.8%
4/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Malaria
|
5.3%
7/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.4%
2/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.6%
5/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pneumonia bacterial
|
7.6%
10/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.1%
3/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
9.4%
13/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Pulmonary tuberculosis
|
5.3%
7/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.8%
4/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.2%
3/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
3/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
10.2%
6/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.1%
7/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
5/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
8.5%
5/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.2%
3/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Alanine aminotransferase increased
|
10.6%
14/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
8.5%
5/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
11.6%
16/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Aspartate aminotransferase increased
|
15.2%
20/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
25.4%
15/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
21.0%
29/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood albumin decreased
|
63.6%
84/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
67.8%
40/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
62.3%
86/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood alkaline phosphatase increased
|
17.4%
23/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
15.3%
9/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
16.7%
23/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood bicarbonate decreased
|
15.9%
21/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
15.3%
9/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
15.9%
22/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood bilirubin increased
|
5.3%
7/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.8%
4/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
3.6%
5/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood creatinine increased
|
10.6%
14/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
15.3%
9/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
9.4%
13/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood glucose decreased
|
6.1%
8/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.8%
4/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
4.3%
6/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood glucose increased
|
15.2%
20/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
18.6%
11/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
17.4%
24/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood phosphorus decreased
|
13.6%
18/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
15.3%
9/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
18.8%
26/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood potassium increased
|
3.8%
5/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.1%
3/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.72%
1/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Blood sodium decreased
|
43.9%
58/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
52.5%
31/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
44.9%
62/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Carbon dioxide decreased
|
6.1%
8/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
15.3%
9/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.2%
3/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Haemoglobin decreased
|
35.6%
47/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
49.2%
29/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
34.8%
48/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Neutrophil count decreased
|
31.8%
42/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
49.2%
29/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
39.9%
55/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Platelet count decreased
|
20.5%
27/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
16.9%
10/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
15.2%
21/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
Weight decreased
|
17.4%
23/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
16.9%
10/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
12.3%
17/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Investigations
White blood cell count decreased
|
4.5%
6/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
10.2%
6/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
9.4%
13/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
11/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.8%
4/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
6.5%
9/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.9%
25/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
18.6%
11/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
12.3%
17/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
7.6%
10/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
13.6%
8/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
8.0%
11/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Headache
|
10.6%
14/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
11.9%
7/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
4.3%
6/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Nervous system disorders
Hypoaesthesia
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
0.00%
0/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.1%
7/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.76%
1/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
8.5%
5/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.2%
3/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Renal and urinary disorders
Dysuria
|
3.8%
5/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.1%
3/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
2.9%
4/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.4%
19/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
22.0%
13/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
19.6%
27/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.6%
14/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
13.6%
8/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
7.2%
10/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.0%
4/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
1.7%
1/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.1%
7/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
3.8%
5/132 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.1%
3/59 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
5.1%
7/138 • From study entry to off study date, average follow-up time of 96 weeks, maximum of 209 weeks.
The study protocol required reporting of all new diagnoses, signs/symptoms \>=Grade 3, lab toxicities \>=Grade 2, and all signs/symptoms and lab toxicities that led to a change in treatment, regardless of grade. All signs/symptoms, lab results, or diagnostic test results observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
|
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
- Publication restrictions are in place
Restriction type: OTHER